Lead Safety Officer
Description✓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 Role:
✓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
✓Your Background:
✓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
✓Apply:
✓It is essential that applicants hold entitlement to work in the UK
✓Please quote job reference 55466 in all correspondence Show more →
✓There will be some hybrid working, 2 days in the office
✓The Role:
✓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
✓Your Background:
✓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
✓Apply:
✓It is essential that applicants hold entitlement to work in the UK
✓Please quote job reference 55466 in all correspondence Show more →