My client is a global Pharmaceutical company with a primary focus on men and women's health. They are operating virtually in Dublin currently with the majority of manufacturing happening in sites throughout Europe. Their Dublin operation forms part of a wider global network and offers great opportunities for career development and professional growth.
The PV Scientist will support the Head of Global Pharmacovigilance (HGPV) and the EEA QPPV to ensure that the pharmacovigilance system is compliant with applicable EU regulatory requirements, act as a vital member of the Global PV team and develop Global processes to ensure consistency and a high level of standard worldwide.
Some areas of responsibility and competency include the following:
- The Pharmacovigilance System Master File (PSMF)
- Awareness, input and authority over the Risk Management Plan (RMP)
- Compilation and review of aggregate reports
- Review Post-Authorisation Safety Study (PASS) protocols
- Review, drafting, updating safety data exchange agreements (SDEAs) and PV agreements
- Degree in Life Sciences
- Minimum 4 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
- Experience specifically in the management of SDEAs and Aggregate Reports highly preferred
- Understands and maintains strong working knowledge of PV global regulations and guidelines with PV operational knowledge
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.