Pharmacovigilance Manager
CK Group are recruiting for a Pharmacovigilance Manager to join a leading pharmaceutical company based in Welwyn Garden City on a 12-month contract basis. As a remote based contractor, you will need to attend the offices on occasion for meetings. Therole has been deemed as Inside IR35.
Pharmacovigilance Manager Role:
The main purpose of the role will be to:
- Management of Individual Case Safety Report (ICSR) from all relevant sources
- Safety Oversight of Studies and Programs, including MAPs, EAMSs and PASS
- Local PV activity classification and oversight of PV contracts
- Service Provider oversight
- Oversight of Risk Management Plan Implementation
- Ensuring PV Quality
Further responsibilities will include:
- Reviewing and coordinating UK QPPV Office communications/information as needed to ensure the UK QPPV and relevant personnel are informed of relevant information received by the UK QPPV Office that affect medical compliance or safety of patients
- Businessmanaging UK QPPV governance and oversight meetings as required and interfacing with stakeholders to ensure appropriate input is provided, drafting minutes and monitoring agreed action status
- Creating, maintaining and executing communication plansand work instructions as needed
- Maintaining knowledge of PV legislation and guidelines and influencing stakeholders to optimize the adherence to highest PV standards described in PV regulations and Roche procedures
Your Background:
To succeed in this role, you will have:
- A healthcare professional or scientific degree is required.
- A broad safety background and experience along with a comprehensive expertise within the Safety environment.
- Experience working with external vendors and local authorities for the oversight of PV contracts.
- Proven track record managing Individual Case Safety Reports (ICSR).
- Prior experience working in and managing a team.
- Experience in the management of the Pharmacovigilance System Master File (PSMF).
Apply:
For more information or to apply for this Pharmacovigilance Manager position, please contact Sam Cupit on 01246457733 or email scupit@ckgroup.co.uk, quoting job ref 52544.
It is essential that applicants hold entitlement to work in the UK.