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