Activity leader, H/F

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Pharmacovigilance Specialist to join their team. The role involves ensuring compliance with regulatory standards, managing client projects, and training junior staff. Candidates should have a pharmacy degree and extensive experience in pharmacovigilance. Proficiency in English and French is essential, along with strong organizational and team management skills. This position offers the opportunity to work on critical projects and contribute to the safety of pharmaceutical products.

Qualifications

• Minimum 5-10 years of experience working for service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Responsabilités

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

Connaissances

Team Management

Organization skills

Team Spirit

Methodical approach

Communicative

Decision-making ability

Rigour

Adaptability

Microsoft Office proficiency

Fluent in English

Fluent in French

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

Social Network Login/Join

PLG is looking for a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and working closely with our PV team to ensure compliance with regulatory standards and accurate safety data.

Responsibilities

1. Serve as key trainer for junior team members to improve quality and expand knowledge of PV case processing.
2. Review and identify areas of 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 a 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.
• 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, Communicative, Decision-making ability, Rigour, Adaptability, Microsoft Office proficiency, Fluent in both English and French (oral and written).