Activity Leader

JR France; Asnières-sur-Seine; 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. The role involves training junior team members, managing client projects, and ensuring compliance with regulatory standards. Candidates should have a pharmacy degree and significant experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years experience in pharmacovigilance or related fields.
• Experience in data entry and management.

Responsabilités

• Key trainer for junior team members to enhance PV case processing.
• Manage larger client projects and monitor client KPIs.
• Perform Quality Control/Medical Review for regulatory compliance.

Connaissances

Team Management

Organization Skills

Communication Skills

Decision-Making Ability

Adaptability

Formation

Pharmacy Graduate

Outils

Microsoft Office

PV Databases

Description du poste

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PLG is looking for a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and working closely with our PV team to ensure compliance with regulatory standards and accurate safety data.

Responsibilities

1. Key trainer for junior team members: Increase quality and expand knowledge of PV case processing.
2. Review and identify areas of improvement.
3. Provide expertise and act as SME: Ensure understanding of tasks by the case management team.
4. Manage larger client projects: Act as single point of contact for the client.
5. Monitor client KPIs.
6. Support in the resolution of NC/CAPA: Identify RCA and implement improvements.
7. Perform Quality Control/Medical Review: Support team to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Ensure understanding of client needs: Meet and exceed expectations.
10. Organize team meetings as requested.

Education and Experience

• Education: Pharmacy graduate.
• Minimum 5-10 years experience: Working for service providers.
• Previous experience: 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, organization 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).