Activity leader, H/F

JR France; Créteil; 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. The role involves training junior team members, managing client projects, and performing quality control. Candidates should have a pharmacy background and extensive experience in the field, with strong organizational and communication skills. Fluency in English and French is required.

Qualifications

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

Responsabilités

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

Connaissances

Communication

Decision-making

Team management

Organizational skills

Adaptability

Formation

Pharmacy graduate

Outils

Microsoft Office

Argus

ArisG

Description du poste

PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. In this role, you will oversee and collaborate closely with our PV team to ensure compliance with regulatory standards and maintain accurate safety data.

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
2. Review cases 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 serve as the 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 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

1. Pharmacy graduate.
2. Minimum 5-10 years of experience working for service providers.
3. Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).
4. Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).
5. Experience working to deadlines.

Knowledge and Skills

1. Understanding of GVP and regulatory standards related to pharmacovigilance.
2. Strong sense of priorities.
3. Team management and organizational skills.
4. Team spirit and methodical approach.
5. Effective communication skills.
6. Decision-making ability.
7. Rigour and adaptability.
8. Fluent in both English and French (oral and written).