Requirements: English
Company: ProductLife Group
Region: Chtenay-Malabry , le-de-France
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:
- Pharmacy Graduate/ Bachelors degree- scientific background
- 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
- Database experience
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
- Emotional intelligence
- Adaptability
- Analytical skills
- Flexibility
- Reliable
- Strong organisation skills
- Punctual
- Database experience