4 Research Director jobs in Ireland
Pharmacovigilance Data Analysis Manager
Posted 21 days ago
Job Viewed
Job Description
**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:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D
Clinical Research Nurse - Cardiology (CNM2)
Posted 4 days ago
Job Viewed
Job Description
Clinical Research Nurse (CNM II)- Cardiology
Posted 361 days ago
Job Viewed
Job Description
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
Posted 2 days ago
Job Viewed
Job Description
Job ID REQ-
Irlanda
SummaryLocation: Barcelona or Dublin
In this role you will effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting the customer expectations while assuring solutions are safe, reliable, scalable and flexible.
You will act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. You will also engage with global business leaders and leverage the appropriate Data Digital and IT (DDIT) teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value
Role Responsibilities:
- Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
- Develop project rationale and perform scoping assessments to determine feasibility of projects. Highlight/identify gaps in existing functionality and review requirements with stakeholders.
- Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions. Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.). Liaise with the service development team to suggest a high level functional solution.
- Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services.
- Ensure the overall user experience is taken into account when designing and deploying new solutions and services.
- Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT )
- Ensure implemented solutions are according to specifications and fit for purpose.
Support super user training.
Role Requirements:
- University degree in Informatics, Computer Sciences, Life Sciences or similar
- A minimum of 10+ years of experience in working in the Pharma or IT Industry with 8+ years of experience in the Lab IT domain
- A minimum of 6+ years of experience as a business analyst/process expert/ business IT lead superuser/Lab data or Digital position
- Expert understanding of business process analysis & design and system architecture concepts.
- Expert understanding of the Lab business processes, drug development experience an advantage
- Expert knowledge of GXP, 21CFR Part 11 and the CSV lifecycle
- Expert knowledge of Lab systems including LIMS systems, and Chromatography systems.
- Ability to solve complex business process / information challenges.
- Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
- Working knowledge of Project Management, agile an advantage
- Prior working experience in TRD and knowledge on TRD business processes is preferred.
- Innovation experiences an advantage, including digital innovation projects
- Data Strategy, Data science or data standardization experience an advantage.
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours
Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
This role is based in Barcelona, Spain OR Dublin, Ireland. Novartis is unable to offer relocation support for this role:please only apply if this location is accessible for you
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Assoc. Director, Business Analyst, Technical Research & Development (TRD)Be The First To Know
About the latest Research director Jobs in Ireland !