CK Group are recruiting for a Local Safety Officer to join a pharmaceutical company at their site based in Gerrards Cross on a permanent basis. There will be some hybrid working, 2 days in the office
The main purpose of the role will be to
- Responsible for performing/overseeing all local PV activities in the designated countries
- Oversee monitoring of local PV legislation and implementation of Risk Management Plans (RMPs)
- Manage local stakeholders as well as local PV vendors.
- Contribute to the maintenance of EU and UK Pharmacovigilance System Master File
Further responsibilities will include:
- Contributing to the enhancement of EU affiliates PV Quality Management System
- Facilitating the local implementation of global processes (ePV regulatory intelligence, management of Safety Data Exchange agreements).
- Implementing PV agreements/SDEAs with local partners/PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered
To succeed in this role, you will come from a life science background in Drug Safety, including previous experience of Pharmacovigilance activity in a UK affiliate
- Possess strong knowledge of International, European and local PV laws and guidance
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55466 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 55466
Website: CK Group
- Posted: 17th May 2023
- Expires: 14th June 2023