Pharmacovigilance Program Director

ProductLife Group; Nantes; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a dedicated Program Director in Pharmacovigilance to lead client projects and ensure adherence to regulatory standards. This role requires a strong background in pharmaceutical regulations and a proven track record in managing client relationships. You will be pivotal in monitoring KPIs, conducting quality reviews, and participating in audits to maintain compliance. If you possess excellent communication skills and a passion for drug safety, this opportunity offers a chance to make a significant impact in a dynamic team environment.

Qualifications

• Minimum 5-10 years experience in service providers.
• Strong understanding of GVP, GCP, FDA regulations.

Responsabilités

• Manage client relationships and act as single point of contact.
• Monitor client KPIs and support resolution of NC/CAPA.
• Perform Quality Control and ensure regulatory compliance.

Connaissances

Effective communication skills

Fluency in English

Fluency in French

Analytical skills

Flexibility

Reliability

Punctuality

Formation

Pharmaceutical background

5-10 years experience in service providers

Description du poste

ProductLife Group is looking for a dedicated Program Director (Pharmacovigilance) to join our dynamic team to oversee and contribute to the activities performed in the Hub :

Responsibilities :

• Manage relationships with larger client projects and act as single point of contact for the client
• Monitor client KPI
• Support in the resolution of NC / CAPA, identify RCA and implement improvements
• Perform Quality Control / Medical Review and provide support to the team where necessary to ensure regulatory compliance
• Participate in audits and inspections as required
• Ensure understanding of client needs and ensure expectations are met and exceeded
• Organise team meetings as requested

Education and Experience :

• Minimum 5-10 years experience working for service providers
• Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
• Previous experience working to deadlines.
• Client communications

Skills :

• Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
• Fluent in both English and French
• Ability to deliver constructive feedback
• Analytical skills
• Flexibility
• Reliable
• Punctual