Activity Leader

JR France; Angers; 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 overseeing a team, ensuring compliance with regulatory standards, and managing client projects. Ideal candidates will have extensive experience in the field and strong communication skills in English and French.

Qualifications

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

Responsabilités

• Train junior team members in PV case processing.
• Review cases and identify improvement areas.
• Manage larger client projects as a single point of contact.

Connaissances

Prioritization

Team Management

Organizational Skills

Effective Communication

Decision-Making

Rigour

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 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 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 needed.
9. Ensure understanding of client needs and exceed expectations.
10. Organize team meetings as required.

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

• Prioritization and team management skills.
• Organizational skills.
• Team spirit and methodical approach.
• Effective communication skills.
• Decision-making ability.
• Rigour and adaptability.
• Fluency in English and French (oral and written).