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. The role 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
- Business managing 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 plans and 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
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).
For more information or to apply for this Pharmacovigilance Manager position, please contact Sam Cupit on 01246457733 or email firstname.lastname@example.org, quoting job ref 52544.
It is essential that applicants hold entitlement to work in the UK.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Contact: Sam Cupit
- Phone: 01246 457700
- Reference: 52544
Website: CK Group
- Posted: 4th January 2022
- Expires: 1st February 2022