Pharmacovigilance Specialist

This role is for a highly skilled Pharmacovigilance Specialist to join our team at Randstad Switzerland. The successful candidate will be responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports.

You will work closely with vendors and the vendor oversight team, as well as the Quality Management team to ensure high-quality standards of PV documents.

• Project management and authoring of aggregate safety reports in collaboration with the PV scientist Lead.
• Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
• Support with process improvement; implements and maintains processes.
• Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).

The ideal candidate will have a BSc degree in biologic or natural science, advanced degree preferred. A minimum of 8 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management, is required.

1. Manage aggregate report processes, including PSURs, DSURs, PADERs, and local reports.
2. Collaborate with the PV scientist Lead to author aggregate safety reports.
3. Provide expertise on safety requirements, company policies/procedures, and aggregate reports knowledge.
4. Contribute to process improvement initiatives.