In this role
You will be responsible for overseeing local pharmacovigilance activities in Switzerland while contributing to the maintenance and development of the quality management system. You will ensure compliance with applicable regulations and support the safe use of medicinal products. The position requires close collaboration with internal teams and external partners in a highly regulated environment.
Start Date
ASAP
Duration
Permanent Position
Place of Work
Neuchâtel
Key Responsibilities
* Act as the local responsible person for pharmacovigilance in Switzerland in accordance with applicable regulatory requirements
* Ensure that all pharmacovigilance activities comply with Swiss and international regulations and guidelines
* Manage safety case processing activities, including collection, assessment, follow-up, and reporting of adverse events
* Ensure timely and accurate submission of safety information to health authorities and partners
* Support the preparation and maintenance of safety documentation such as periodic safety reports, risk management plans, and related deliverables
* Conduct literature monitoring and contribute to signal detection and evaluation activities
* Maintain and oversee safety data exchange agreements and coordinate with external stakeholders and service providers
* Support audits, inspections, and interactions with regulatory authorities in the area of pharmacovigilance
* Contribute to the maintenance and continuous improvement of the quality management system
* Prepare, review, and update quality documents such as SOPs and working instructions
* Support quality processes including deviations, CAPAs, change controls, and risk assessments
* Participate in internal audits and ensure inspection readiness
* Ensure alignment between pharmacovigilance activities and the overall quality framework
* Provide support to quality processes related to clinical activities when required
Candidate Profile
* Degree in Life Sciences, Pharmacy, Medicine, or a related discipline
* Several years of experience in pharmacovigilance and quality-related roles within the pharmaceutical industry
* Strong knowledge of Swiss pharmacovigilance regulations and international guidelines such as EU GVP
* Experience in safety case management and regulatory reporting
* Familiarity with quality management systems and related processes
* Strong organizational skills and ability to manage multiple priorities in a structured manner
* Excellent communication and stakeholder management skills
* Ability to work independently in a regulated and dynamic environment
* Fluent in English, French, and German
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