Activity leader, H/F

JR France; Puteaux; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist to oversee compliance with regulatory standards. The role involves training junior members, managing client projects, and ensuring accurate safety data. Candidates should have a pharmacy degree and extensive experience in the field.

Qualifications

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

Responsabilités

• Serve as key trainer for junior team members.
• Manage larger client projects and monitor client KPIs.
• Perform Quality Control/Medical Review.

Connaissances

Team management

Effective communication

Decision-making

Organizational skills

Adaptability

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. In this role, you will oversee and collaborate closely with our PV team to ensure compliance with regulatory standards and maintain accurate safety data.

Responsibilities

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

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

Knowledge and Skills

• Understanding of GVP and regulatory standards related to pharmacovigilance.
• Strong sense of priorities.
• Team management and organizational skills.
• Team spirit and methodical approach.
• Effective communication skills.
• Decision-making ability.
• Rigour and adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).