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Pharmacovigilance & Medical Affairs Manager

Company

Zentiva Group, a.s.

Location

Guildford, United Kingdom

Type

Full time

Position Purpose
The PV and Medical Affairs Manager provides pharmacovigilance and medical affairs expertise, leadership, mentorship, and supervision, and supports the management of medical, scientific, and administrative responsibilities.
The role is responsible for the development and implementation of PV and Medical Affairs strategy, processes, and platforms, ensuring compliance with legislation and company procedures and the efficient delivery of PV and Medical Affairs services.


Key Responsibilities and Duties
Pharmacovigilance

  • Act as the UK National Contact Person for Pharmacovigilance (NCPP) and primary PV contact for the MHRA.
  • Maintain oversight of all UK pharmacovigilance cases, including those received via health authorities.
  • Monitor compliance of UK PV case management and aggregate report submissions.
  • Author and maintain the UK Pharmacovigilance System Master File (PSMF).
  • Ensure the UK Quali...
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