Deputy Pharmacovigilance Manager

il y a 1 semaine


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).RoleThe Deputy Pharmacovigilance Manageris 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 ResponsibilitiesPlanning, coordination, staffing and organizing activities of the Pharmacovigilance Officers, Pharmacovigilance Assistant and Quality Officers within the Pharmacovigilance teamMonitoring and compliance of the activities outsourced by the Customer, according to the contractsSOPs / WIs : preparation, review, updateAny 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, updateManagement of Health Authority requests in respect of timelinesRegulatory monitoring : impact assessment on the Customer’s systemCCSI / CCDS : preparation, review, updateRMP : preparation, review, updateInvolvement in customers’ partners PV agreements drafting, maintenance of the contracts’ tracking table.Back-up activitiesPharmacovigilance Managers duties in the absence of the PV manager : Planning, coordination and organizing routine activities of the Pharmacovigilance Project ManagersOtherResponsibility 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 authorizationsGroup 13 ProfileScientist or PharmacistAt least 5 years’ experience in PV activities especially in case management, safety writing, risk management and signal detection.Can be acted as deputy RPVHaving worked with multiple clients, different PV system for minimum of 5 yearsDirect participation in inspections from the health authoritiesTeam management of Pharmacovigilance officers #J-18808-Ljbffr



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