Activity leader, H/F

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

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist to oversee case processing and ensure compliance with regulatory standards. The role involves training junior team members, managing client projects, and conducting quality reviews. Candidates should have significant experience in the field and be proficient in relevant databases and Microsoft Office.

Qualifications

• Minimum 5-10 years of experience working with service providers.
• Previous experience in data entry, management, or 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

Prioritization

Organization

Team management

Communication

Decision-making

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. This role involves overseeing and collaborating closely with our PV team to ensure compliance with regulatory standards and accurate safety data management.

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand their knowledge of PV case processing.
2. Review cases and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring clear 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 resolving NC/CAPA, identify root causes, 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

• Prioritization and organization skills.
• Team management and team spirit.
• Methodical approach and good communication skills.
• Decision-making ability.
• Rigour and adaptability.
• Proficiency in Microsoft Office.
• Fluency in both English and French (oral and written).