Activity leader, H/F

JR France; Le Havre; 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. This role involves training junior members, managing client projects, and performing quality control. The ideal candidate will have a pharmacy background and extensive experience in pharmacovigilance. Fluency in English and French is required.

Qualifications

• Minimum 5-10 years of experience working for service providers.
• Previous experience in pharmacovigilance (preferably 5+ years).

Responsabilités

• Serve as the key trainer for junior team members.
• Manage larger client projects and act as the single point of contact.
• Perform Quality Control/Medical Review to ensure compliance.

Connaissances

Team Management

Organization skills

Effective communication

Decision-making ability

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.

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge in PV case processing.
2. Review and identify areas for improvement.
3. Act as SME for the team, ensuring understanding of tasks by the case management team.
4. Manage larger client projects and act as the single point of contact for the client.
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 and exceeded.
10. Organize team meetings as needed.

Education and Experience

• Pharmacy graduate.
• Minimum 5-10 years of experience working for service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills & 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

• Sense of priorities
• Team Management
• Organization skills
• Team Spirit
• Methodical approach
• Effective communication
• Decision-making ability
• Rigour
• Adaptability
• Fluent in both English and French (Oral and Written)