Activity leader, H/F

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

Résumé du poste

A leading company is seeking a dedicated Pharmacovigilance Specialist - Case Processing to oversee compliance with regulatory standards and maintain accurate safety data. The role involves training junior staff, managing client projects, and ensuring quality control. The ideal candidate will have a pharmacy degree and extensive experience in pharmacovigilance, along with strong organizational and communication skills.

Qualifications

• Minimum 5-10 years of experience in pharmacovigilance.
• Previous experience in data entry and management.

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

Organization skills

Good communication 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 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 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

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Sense of priorities.
• Team management.
• Organization skills.
• Team spirit.
• Methodical approach.
• Good communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).