ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Brest; 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 involves training junior team members, managing client projects, and performing quality control. The ideal candidate will have extensive experience in pharmacovigilance and strong organizational skills.

Qualifications

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

Responsabilités

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

Connaissances

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 the key trainer for junior team members, enhancing quality and expanding 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 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 and support the team 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 requested.

Education and Experience:

• Pharmacy graduate.
• Minimum 5-10 years experience working for 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:

• Sense of priorities, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigor, adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).