Deputy Pharmacovigilance Manager - VAF247

Groupe ProductLife; Lyon; Sur place; EUR 40 000 - 80 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un Deputy Pharmacovigilance Manager pour superviser les activités de pharmacovigilance. Dans ce rôle, vous serez responsable de la planification, de la coordination et de l'organisation des activités de l'équipe de pharmacovigilance, tout en garantissant la conformité aux réglementations. Avec au moins 5 ans d'expérience dans le domaine, vous aurez l'opportunité de travailler avec divers clients et systèmes de pharmacovigilance. Ce poste temporaire de 7 à 8 mois offre un environnement dynamique où vos compétences en gestion de projet et en sécurité seront mises à l'épreuve. Rejoignez une équipe dédiée à la sécurité des patients et à l'excellence opérationnelle.

Qualifications

• Minimum 5 ans d'expérience en pharmacovigilance, notamment en gestion de cas et rédaction de sécurité.
• Expérience directe avec des inspections des autorités sanitaires.

Responsabilités

• Planification et coordination des activités des agents de pharmacovigilance.
• Gestion des demandes des autorités de santé selon les délais.

Connaissances

Gestion de la sécurité

Gestion des risques

Détection des signaux

Gestion de projet

Rédaction de rapports de sécurité

Formation

Scientifique ou Pharmacien

Description du poste

Deputy Pharmacovigilance Manager - VAF247

Lyon

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Onsite

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Life Cycle

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Safety and Vigilance

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Fixed term

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.
• 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.