Pharmacovigilance Manager

vor 2 Wochen

Basel, Schweiz CSL Behring Vollzeit

At this position, you are part of the Regulatory Affairs and Pharmacovigilance Team within the Medical Department of the Swiss affiliate at CSL Vifor (no direct reports). You are the main responsible person for independently processing drug safety reports for our products. You perform your tasks in collaboration with other colleagues of the same team as well as with internal and external partners. Following responsibilities are related to this position:

- Collecting, processing and archiving of all spontaneous drug safety reports in Switzerland
- Performing and archiving of follow-ups in Switzerland
- Medical assessment of individual drug safety reports
- Timely and compliant reporting of all drug safety reports to CSL Vifor headquarter and licensing partners
- Performing reconciliation
- E2B-compliant data entry in the electronic drug safety database
- Performing signal and risk management activities
- Maintaining the Pharmacovigilance Quality Management System in compliance with GVP as well as participation in internal and external audits/inspections
- Planning, execution and documentation of internal and external drug safety trainings
- Performing Regulatory Intelligence and local literature screening
- Active collaboration with and support of Qualified Person for Pharmacovigilance

For this demanding role, we are looking for a well-organized person bringing the following profile:

- University degree in pharmacy, medical or natural science
- Proven knowledge of Pharmacovigilance with prior experience in pharmaceutical industry
- Prior experience with MS Office tools and with electronic databases
- Native French or German speaker with very good command of the other language, and fluent in English

You are perfect for our team if you hold strong analytical skills and intend to solve problems with a methodical approach. You have an accurate and service-oriented way of working and feel comfortable in communicating with others. Curious and enthusiastic, you take up new challenges and you actively contribute to the safety of our products.

**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Vifor**:

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