ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Laval; 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 includes training junior team members, managing client projects, and performing quality control to maintain high safety data management standards.

Qualifications

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

Responsabilités

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

Connaissances

Prioritization

Team management

Communication

Decision-making

Adaptability

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

Job Description:

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 accurate safety data management.

Responsibilities:

1. Serve as the 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 clear understanding of 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 to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Understand client needs and ensure expectations are met or exceeded.
10. Organize team meetings as needed.

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