Pharmacovigilance Program Director

ProductLife Group; Paris; 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 compliance with regulatory standards. This role involves managing client relationships, monitoring KPIs, and providing quality control support to the team. The ideal candidate will have a strong pharmaceutical background, deep knowledge of pharmacovigilance principles, and excellent communication skills in both English and French. Join this dynamic team and contribute to impactful drug safety initiatives while ensuring client expectations are not just met, but exceeded.

Qualifications

• Minimum 5-10 years experience working for service providers.
• Strong understanding of GVP, GCP, FDA and regulatory requirements.

Responsabilités

• Manage relationships with larger client projects and act as single point of contact.
• Perform Quality Control / Medical Review and ensure regulatory compliance.

Connaissances

Effective communication skills

Fluent in English

Fluent in French

Analytical skills

Flexibility

Reliability

Punctuality

Formation

5-10 years experience in service providers

Pharmaceutical background

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