Activity Leader

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

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist - Case Processing. This role involves training junior staff, managing client projects, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmacovigilance and be proficient in relevant databases. Fluency in English and French is required.

Qualifications

• 5-10 years experience in service providers, with 5+ years in pharmacovigilance.
• Experience in data entry and management.

Responsabilités

• Train junior team members in PV case processing.
• Manage client projects and monitor KPIs.
• Perform Quality Control and support regulatory compliance.

Connaissances

Prioritization

Organization

Team Management

Communication

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 collaborating closely with our PV team to ensure compliance with regulatory standards and accurate safety data management.

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 proper 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 issues, identify root causes, 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 needed.

Education and Experience

• Pharmacy graduate.
• Minimum 5-10 years experience in service providers, with 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

• Prioritization and organization skills.
• Team management and team spirit.
• Methodical approach and strong communication skills.
• Decision-making ability.
• Rigour and adaptability.
• Fluency in both English and French (oral and written).