Activity leader, H/F

JR France; La Roche-sur-Yon; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company is seeking a dedicated Pharmacovigilance Specialist to oversee compliance and safety data accuracy. The role includes training junior members, managing client projects, and ensuring regulatory adherence. Ideal candidates have extensive experience in pharmacovigilance and strong communication skills.

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 for clients.
• Perform Quality Control/Medical Review and support regulatory compliance.

Connaissances

Team management

Organizational skills

Strong communication skills

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 the accuracy of safety data.

Responsibilities

1. Serve as the key trainer for junior team members to enhance the quality and expand 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 act as the single point of contact for clients.
5. Monitor client KPIs.
6. Support in the resolution of 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 that expectations are met or exceeded.
10. Organize team meetings as requested.

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

• Proficiency in Microsoft Office.
• Familiarity with PV databases (e.g., Argus, ArisG).

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

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