* Location: Neuchâtel, Switzerland (on-site)
* Commencement: Preferred at the earliest date or 1st of June
* Languages Required: Fluent English, French and German (spoken and written)
About the Role:
We are seeking an experienced Pharmacovigilance and Quality Manager (Local PV - Switzerland) to join our team in Neuchâtel. The role covers pharmacovigilance activities to ensure the safe and compliant use and distribution of medicinal products in Switzerland as well as partial responsibilities in Quality Management Systems (QMS). The role will act as a key contributor to the pharmacovigilance system framework. The position is fully on-site and requires close collaboration with internal and external stakeholders.
Key Responsibilities:
* Act as “Local Person Responsible for Pharmacovigilance” (LPPV) in accordance with Swiss law and regulatory requirements
* Perform pharmacovigilance activities in compliance with Swissmedic, EU GVP, and applicable international regulations
* Manage and process Individual Case Safety Reports (ICSRs), including case intake, follow-up, assessment, and reporting
* Ensure timely submission of safety reports to relevant authorities and partners
* Contribute to the preparation, review, and maintenance of PSURs/PBRERs, RMPs, and other safety documents
* Perform literature surveillance and signal management activities
* Maintain and manage safety data exchange agreements and collaboration with partners, distributors, and service providers
* Participate in audits, inspections, and regulatory interactions related to pharmacovigilance
Quality Management System (QMS):
* Contribute to maintenance and continuous improvement of the Quality Management System
* Draft, review, and update SOPs, working instructions, and quality documents
* Support deviation management, CAPAs, change controls, and risk assessments
* Participate in internal audits and inspection readiness activities
* Ensure alignment of pharmacovigilance activities within the QMS framework
* When and if needed: maintain and develop QMS system linked to clinical trials activities to ensure GCP compliance (e.g. SOPs review and development).
Requirements:
* Degree in Life Sciences, Pharmacy, Medicine, or a related field
* At least 6 to 8 years of experience in pharmacovigilance, quality assurance and documentation management within the pharmaceutical industry
* Solid knowledge of Swissmedic and EU GVP requirements
* Strong interpersonal and communication skills with the ability to build collaborative relationships
* Proactive, detail-oriented, work independently and able to manage multiple priorities in a regulated environment
* Experience with audits and health authority inspections
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