Deputy Pharmacovigilance Manager - VAF

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