Activity leader, H/F

JR France; Ivry-sur-Seine; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is looking for a dedicated Pharmacovigilance Specialist to oversee compliance and safety data accuracy. This role involves training junior staff, managing client projects, and ensuring regulatory adherence. The ideal candidate will have a pharmacy background and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years of experience with service providers.
• Previous experience in pharmacovigilance preferred.

Responsabilités

• Serve as key trainer for junior team members.
• Manage larger client projects and serve as single point of contact.
• Ensure regulatory compliance through Quality Control.

Connaissances

Team Management

Communication

Decision-Making

Adaptability

Formation

Pharmacy Graduate

Outils

Microsoft Office

PV Databases

Description du poste

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PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and collaborating closely with our PV team to ensure compliance with regulatory standards and the accuracy of safety data.

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge in PV case processing.
2. Review cases and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring understanding of tasks by the case management team.
4. Manage larger client projects and act as the single point of contact for clients.
5. Monitor client KPIs.
6. Support in resolving NC/CAPA, identify RCA, and implement improvements.
7. Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Ensure understanding of client needs and meet or exceed expectations.
10. Organize team meetings as requested.

Education and Experience

• Pharmacy graduate.
• Minimum 5-10 years of experience working with service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills

• Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Sense of priorities, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigour, adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).