Activity leader, H/F

JR France; Aix-en-Provence; 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 case processing and ensure compliance with regulatory standards. This role involves training junior team members, managing client projects, and performing quality control to maintain high safety data accuracy. The ideal candidate will have a pharmacy background and extensive experience in the field.

Qualifications

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

Responsabilités

• Key trainer for junior team members in PV case processing.
• Manage larger client projects and monitor client KPIs.
• Perform Quality Control/Medical Review for regulatory compliance.

Connaissances

Prioritization

Team Management

Organizational Skills

Communication Skills

Decision-Making

Adaptability

Formation

Pharmacy Graduate

Outils

Microsoft Office

PV Databases

Description du poste

Social Network Login/Join

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

Responsibilities

1. Key trainer for junior team members to enhance quality and knowledge of PV case processing.
2. Review 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 serve 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. Understand client needs and ensure expectations are met or exceeded.
10. Organize team meetings as requested.

Education and Experience

• Education: Pharmacy graduate.
• Minimum 5-10 years 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).
• Experience working to deadlines.

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Prioritization, team management, organizational skills, team spirit, methodical approach, communication skills, decision-making, rigor, adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).