Pharmacovigilance à United States

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
• 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