QPPV Team Lead
Posted on Mar 9, 2021 by Real Staffing Group
My client, a well-established Pharmaceutical company based in Athlone, are looking for a QPPV to join their team.
As QPPV, you would be responsible for establishment and maintenance of the Marketing Authorisation holder's pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
You will also lead the Pharmacovigilance team supporting 3 direct reports.
Key Responsibilities as QPPV;
- Update and manage the company's Pharmacovigilance systems in line with legal requirements
- Manage and oversee external PV Providers
- Oversee the maintenance of the PV system SOP's and the associated PSMF
- Ensure all PSUR and medical variation applications are planned, tracked and obtained in a timely manner
- Maintain a program for audit pharmacovigilance system and Service Providers
- Review and update PV agreements for all contractual arrangements and ensure reconciliations are carried out as outlined in the agreement
- Provide Pharmacovigilance support and advice to relevant departments
- Track and highlight updates to EMA and local drug legislation as it applies to EU and UK regulatory Pharmacovigilance requirements for investigational and post-marketing drug/biologic products
Education & Experience;
- Degree in Pharmacy, Biology, Nursing, Toxicology, Medicine or an equivalent degree from the Life Science field
- 3- 5 years of experience in Pharmacovigilance/Drug Safety/Medical Information within a commercial Pharmaceutical Environment (E)
- Demonstrable Expert knowledge in EU and UK PV legislation Experience in regulatory agency inspection planning, preparation, conduct, management and agency interactions
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales