PV Compliance Manager

4 days ago


Pretoria, Gauteng, South Africa 卡湯晩 Full time
About the Job

This position is ideal for an individual with a strong background in pharmacovigilance and regulatory affairs. You will be responsible for managing complex tasks with tight deadlines, handling regulatory and medical aspects, and communicating effectively with internal and external stakeholders.

Key Responsibilities:
  • Managing and maintaining a local PV system in accordance with global Sanofi group procedures.
  • Coordinating with the CSS to implement and document a PV Quality System.
  • Ensuring compliance with global procedures to meet regulatory obligations and commitments.
  • Assisting in ensuring timely completion of audit and inspection observations and ensuring permanent inspection readiness for PV activities.
  • Supporting with PV training, quality document preparation, deviation management.
  • Ensuring effective communication with internal and external stakeholders about safety information.
  • Monitoring and reviewing incoming communication to identify ICSRs and other safety information needing reporting to PSPV / Global PV entities, HAs, Partners.
  • Interaction with global vendor(s) and PSPV when required.
  • Supporting with periodic reports, risk management, signal management, PV contracts, digital projects, patient programs.

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