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Pharmacovigilance and Quality Manager (Local PV)
GALSER SA · Neuchâtel
Description du poste
About the role
We are looking for an experienced Pharmacovigilance and Quality Manager to lead local PV activities in Switzerland. Based in Neuchâtel, the role ensures safe, compliant use of medicinal products and supports the continuous improvement of our Quality Management System.
Key responsibilities
- Act as the Local Person Responsible for Pharmacovigilance (LPPV) in line with Swiss law and EU GVP.
- Manage the full lifecycle of Individual Case Safety Reports, from intake to regulatory submission.
- Prepare and maintain PSURs/PBRERs, Risk Management Plans and other safety documentation.
- Conduct literature surveillance, signal detection and safety data exchange with partners.
- Support audits, inspections and regulatory interactions for pharmacovigilance.
- Contribute to QMS maintenance, SOP drafting, deviation handling, CAPA, change control and risk assessments.
- Participate in internal audits and ensure alignment of PV activities within the QMS framework.
Required profile
- Degree in Life Sciences, Pharmacy, Medicine or related field.
- 6‑8 years of experience in pharmacovigilance and quality assurance within the pharmaceutical industry.
- Strong knowledge of Swissmedic and EU GVP regulations.
- Excellent interpersonal and communication skills, able to work independently and manage multiple priorities.
Required skills
- Pharmacovigilance
- Quality Management System (QMS)
- Swissmedic regulatory compliance
- EU GVP compliance
- Individual Case Safety Report (ICSR) processing
- PSUR/PBRER preparation
- Risk Management Plan (RMP) development
- Literature surveillance
- Signal management
- Standard Operating Procedure (SOP) drafting
- CAPA management
- Change control
- Risk assessment
- Audit and inspection support
- GDP training
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GALSER SA
Neuchâtel
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