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Act as the local responsible person for pharmacovigilance in Switzerland in accordance with applicable regulatory requirements
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Ensure that all pharmacovigilance activities comply with Swiss and international regulations and guidelines
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Manage safety case processing activities, including collection, assessment, follow-up, and reporting of adverse events
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Ensure timely and accurate submission of safety information to health authorities and partners
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Support the preparation and maintenance of safety documentation such as periodic safety reports, risk management plans, and related
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eliverables
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Conduct literature monitoring and contribute to signal detection and evaluation activities
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Maintain and oversee safety data exchange agreements and coordinate with external stakeholders and service providers
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Support audits, inspections, and interactions with regulatory authorities in the area of pharmacovigilance
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Contribute to the maintenance and continuous improvement of the quality management system
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Prepare, review, and update quality documents such as SOPs and working instructions
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Support quality processes including deviations, CAPAs, change controls, and risk assessments
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Participate in internal audits and ensure inspection readiness
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Ensure alignment between pharmacovigilance activities and the overall quality framework
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Provide support to quality processes related to clinical activities when required