Pharmacovigilance Data Analysis Manager
Sant Cugat del Valles, IE
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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. |
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At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Position Summary:
What You'll Do:
- 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.
Our Benefits Include :
- Highly competitive salary
- Annual performance-based bonus
- Share options scheme
- Group pension scheme with company matching contributions
- Private Medical Insurance
- Ongoing opportunities for career development
- Succession planning and internal promotion opportunities
- Education assistance
- Wellness and social activities
- Collaborative and inclusive working environment
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply—we're excited to hear from you
Location: Grange Castle International Business Park, Clondalkin, Dublin, Ireland.