Activity leader, H/F

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

Résumé du poste

A leading company is seeking a dedicated Pharmacovigilance Specialist to oversee case processing and ensure compliance with regulatory standards. The role involves training junior members, managing client projects, and performing quality control. The ideal candidate will have extensive experience in pharmacovigilance and strong communication skills in both English and French.

Qualifications

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

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

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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 accurate safety data.

Responsibilities

1. Serve as a 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 clear 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 the resolution of NC/CAPA, 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 of experience working with service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills and Knowledge

• Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).
• Experience working to deadlines.
• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

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