ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; La Roche-sur-Yon; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading company is looking for a dedicated Pharmacovigilance Specialist - Case Processing to oversee safety data management and regulatory compliance. The role involves training junior staff, managing client projects, and ensuring quality control. Candidates should have a pharmacy background and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years of experience working with service providers.
• Previous experience in pharmacovigilance preferred (5+ years).

Responsabilités

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

Connaissances

Prioritization

Team management

Organizational skills

Effective 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 of PV case processing.
2. Review processes and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring task understanding by case management staff.
4. Manage larger client projects and serve as the primary contact for clients.
5. Monitor client KPIs.
6. Support 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 needed.
9. Understand client needs and ensure expectations are met or exceeded.
10. Organize team meetings as required.

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).

Technical Skills:

• Proficiency in Microsoft Office.
• Familiarity with PV databases (e.g., Argus, ArisG).

Knowledge:

• Understanding of GVP and related regulatory standards.

Skills:

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