Requirements: English
Company: ProductLife Group
Region: Bordeaux , Nouvelle-Aquitaine
PLG is looking for a dedicated Pharmacovigilance Activity Manager- Case Processing to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.
Responsibilities
- Key trainer for junior team members to increase quality and expand knowledge of PV case processing
- Review and identify areas of improvement
- Provide expertise and act as SME for the team, ensuring understanding of tasks by case management team
- Manage 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
- Education: 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).
- Previous experience working to deadlines
- Knowledge: Understanding of GVP and regulatory standards related to pharmacovigilance.
Skills
- Sense of priorities
- Team Management
- Organization skills
- Team Spirit
- Methodical
- Communicant
- Ability to make decisions
- Rigour
- Adaptability
- Microsoft office
- Fluent in both English and French (Oral and Written)