ENGLISH SPEAKING ACTIVITY ASSISTANT

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

Résumé du poste

A leading company is seeking a dedicated Pharmacovigilance Specialist to oversee compliance and safety data management. The role involves training junior members, managing client projects, and ensuring regulatory standards are met. Candidates should have extensive experience in pharmacovigilance and strong communication skills.

Qualifications

• Minimum 5-10 years of experience in pharmacovigilance.
• Experience in data entry and management.

Responsabilités

• Serve as key trainer for junior team members.
• Manage larger client projects and monitor client KPIs.
• Perform Quality Control and support regulatory compliance.

Connaissances

Prioritization

Organization

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 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 requested.

Education and Experience:

• Pharmacy graduate.
• Minimum 5-10 years of experience working for service providers, preferably in pharmacovigilance.
• 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, rigor, and adaptability.
• Fluent in both English and French (oral and written).