Senior Manager, PV Safety & Risk Management EMENA
Source: Talent GB
Due to company growth we have an exciting opportunity to offer with this new position within our Scientific Affairs department, we’re looking for a senior SME for Pharmacovigilance Safety & Risk Management to support and be Co-Deputy to the Director of PV Safety & Risk Management EMENA, focussing on products with additional Risk Minimisation Measures (aRMM). You will be responsible for co-ordinating and overseeing all pharmacovigilance activities performed by Accord’s Safety and Risk Management Team members, and ensuring proper support in the qualitative MAH review of PhV aggregate safety reports, signal detection reports or risk management plans delivered by the service provider.
You’ll participate in pharmacovigilance/cross-functional initiatives to develop and implement policies and procedures (aligning with requirements of regulatory authorities, global polices and best practices) relating to the benefit-risk profile of Accord’s products and establish medical and scientific leadership for understanding and responding to the safety and risk profile of Accord products, both in development and on the market. You’ll also assess and approve clinical safety requirements in protocols, safety management plans or contracts for clinical trials or other types of organised data collection systems Accord participates in.
In return, we offer a competitive salary and rewards package (including increased holiday, annual bonus scheme and a company pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.
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