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.

Group 10
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):
  • PSURs and ACO: preparation, review, update
  • Signal detection activities
  • Management of Health Authority requests in respect of timelines
  • Regulatory monitoring: impact assessment on the Customer’s system
  • CCSI/CCDS: preparation, review, update
  • RMP: preparation, review, update
  • 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

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

Group 13
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

Deputy Pharmacovigilance Manager - VAF247

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