Deputy Pharmacovigilance Manager

il y a 6 jours

Lyon, France ProductLife Group Temps plein

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.

**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
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

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