Vifor Pharma is a world leading specialty pharmaceutical company. Our pharmaceutical business focuses on the development, manufacture and marketing of anemia products and the development of medicines for the treatment of renal related autoimmune diseases. Our consumer healthcare business manufactures both internally developed and in-licensed products, which we market internationally.
We are currently looking for a medical writer based in Glattbrugg/Zurich. Reporting to our Head of Medical Writing Unit based in Geneva (Switzerland), you will contribute to excellence in PV document coordination and writing by:
Production of high quality periodic and cumulative aggregate safety reports (e.g. PSURs, PBRERs, DSURs, RMPs, Addendum and Summary Bridging report, etc.) for the different Vifor products in compliance with ICH, FDA and EMA guidelines
Participation in signal detection and assessment
Quality control of reports written internally and from external support
Timely handling of aggregate safety reports to Regulatory Affairs (RA) for compliant submissions
Providing support for compliance of benefit/risk surveillance to Clinical, Medical, Regulatory and Safety teams (CMRSTs),
Effective and timely implementation of CAPA as result of Audits and Inspections
Maintenance of updated SOPs as per new regulations and change in processes
Developing further support activities of the Medical and Clinical Safety Center of Excellence
The ideal candidate will hold a university degree in pharmacology, medical or other life science field. Additionally, you will have the following profile:
Minimum of 5 years of working experience in post marketing surveillance / drug safety operations including: medical writing of ASRs, case classification, causality, labelling, MedDRA, WHO-Drug coding and narratives
Good understanding of aggregate reporting; benefit-risk assessment; signal detection and risk management
Good knowledge of ICH, FDA and EMA guidelines
Fluency in English
Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
Strong analytical skills
This is a fantastic opportunity to be a part of an interesting and challenging function in a motivated team as well as the advantages of a modern company with excellent social benefits.
If this opportunity is of interest to you, please apply by submitting your updated CV via our careers portal.