ENGLISH SPEAKING ACTIVITY ASSISTANT

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

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist - Case Processing. The role involves overseeing the PV team, ensuring compliance with regulatory standards, and managing client projects. The ideal candidate will have extensive experience in pharmacovigilance and strong communication skills in both English and French.

Qualifications

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

Responsabilités

• Serve as a key trainer for junior team members.
• Manage larger client projects and act as single point of contact.
• Perform Quality Control/Medical Review to ensure compliance.

Connaissances

Prioritization

Team Management

Organization Skills

Communication Skills

Decision-Making Ability

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 a 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 case management staff.
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, supporting the team to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Understand client needs and ensure their expectations are met or exceeded.
10. Organize team meetings as needed.

Education and Experience:

• Pharmacy graduate with a minimum of 5-10 years' experience working with service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills:

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

Knowledge:

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills:

• Prioritization, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigor, adaptability.
• Fluent in both English and French (oral and written).