3 Research Scientist jobs in Ireland
Research Scientist - Pharma
Athlone, Leinster
ThermoFisher Scientific
Posted today
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Research Scientist, Pharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The Research Scientist conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. They design and execute method development/validation independently and interpret and review analytical data for self and others. They will routinely act as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.
**A day in the life:**
+ Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceuticals, specifically for techniques related to Physical and Chemical Characterization (for example HIAC, KF, FTIR, MFI, auto-titration)
+ Designs and executes experiments independently for self and others.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists business development group in technical sales and marketing
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
+ Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Education and Experience**
+ Min. Degree or equivalent in Chemistry or similar
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ 8+ years experience that provides the knowledge and skills to perform the job
+ Significant industry experience within an analytical testing laboratory and GMP environment is essential
**Knowledge, Skills, Abilities**
+ Extensive technical expertise in equipment related to physical and chemical characterization of pharmaceutical products including but not limited to HIAC, KF, FTIR, MFI.
+ Ability to learn quickly and dedicate time to method/technical research into current techniques falling within physical testing team and new techniques that may be on-boarded in the future.
+ Proven experience of method development and validation
+ Ability to project management and deal with client audits
+ Ideally experience in leading CMC studies including method validation
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Research Scientist, Pharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The Research Scientist conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. They design and execute method development/validation independently and interpret and review analytical data for self and others. They will routinely act as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.
**A day in the life:**
+ Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceuticals, specifically for techniques related to Physical and Chemical Characterization (for example HIAC, KF, FTIR, MFI, auto-titration)
+ Designs and executes experiments independently for self and others.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists business development group in technical sales and marketing
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
+ Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Education and Experience**
+ Min. Degree or equivalent in Chemistry or similar
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ 8+ years experience that provides the knowledge and skills to perform the job
+ Significant industry experience within an analytical testing laboratory and GMP environment is essential
**Knowledge, Skills, Abilities**
+ Extensive technical expertise in equipment related to physical and chemical characterization of pharmaceutical products including but not limited to HIAC, KF, FTIR, MFI.
+ Ability to learn quickly and dedicate time to method/technical research into current techniques falling within physical testing team and new techniques that may be on-boarded in the future.
+ Proven experience of method development and validation
+ Ability to project management and deal with client audits
+ Ideally experience in leading CMC studies including method validation
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
0
Sr Research Scientist - Pharma
Athlone, Leinster
ThermoFisher Scientific
Posted today
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
1
Pharmacovigilance Data Analysis Manager
Dublin, Leinster
Grifols Shared Services North America, Inc
Posted today
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:**
**Type:** Indefinido tiempo completo
**Job Category:** I + D
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:**
**Type:** Indefinido tiempo completo
**Job Category:** I + D
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Research scientist Jobs in Ireland !
2