Job Details
VAF247 - Deputy Pharmacovigilance Manager (temporary contract)
[Lyon, 69001],  Rhône-Alpes,  France | Posted - 16/04/2025
Job Description

Stragen Services, a Productlife Group company, is looking for a Deputy Pharmacovigilance Manager to join their team for a temporary contract (7-8 months).
 
Role
The Deputy Pharmacovigilance Manager:
- is responsible for effective planning, delegating, coordinating, staffing and organizing the routine activities of the Pharmacovigilance officers at Stragen Services.
- endorses also the role of Pharmacovigilance Project Manager for designated customer(s).
- can deputize the Pharmacovigilance Manager when applicable.
- is responsible to perform his duties in accordance with applicable regulations.
 
Main Responsibilities
  • Planning, coordination, staffing and organizing activities of the Pharmacovigilance Officers, Pharmacovigilance Assistant and Quality Officers within the Pharmacovigilance team
  • Monitoring and compliance of the activities outsourced by the Customer, according to the contracts
  • SOPs/WIs: preparation, review, update
  • Any other pharmacovigilance related tasks (training, audit ...)
  • Project manager role, including overall follow-up of designated client(s): specific requirements and compliance to deadlines. Involvement in any pharmacovigilance activities, including (but not limited to):
o PSURs and ACO: preparation, review, update
o Signal detection activities
o Management of Health Authority requests in respect of timelines
o Regulatory monitoring: impact assessment on the Customer’s system
o CCSI/CCDS: preparation, review, update
o RMP: preparation, review, update
o Involvement in customers’ partners PV agreements drafting, maintenance of the contracts’
tracking table.

Back-up activities
  • Pharmacovigilance Managers duties in the absence of the PV manager: Planning, coordination and organizing routine activities of the Pharmacovigilance Project Managers
3/ Other
  • Responsibility of Qualified Person for Pharmacovigilance (QPPV) / RPV (FR) / UK QPPV or Deputy when applicable.
  • Perform all other duties as assigned by the Pharmacovigilance Manager / the General Manager, within the limit of employee authorizations
Profile
  • Scientist or Pharmacist
  • At least 5 years' experience in PV activities especially in case management, safety writing, risk management and signal detection.
  • Can be acted as deputy RPV
  • Having worked with multiple clients, different PV system for minimum of 5 years
  • Direct participation in inspections from the health authorities
  • Team management of Pharmacovigilance officers