Vifor Pharma
Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Stellentyp: Vollzeit

Medical Writer - Zurich

Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
Medha Khanna
Senior Talent Acquisition Manager
+41 58 852 90 82
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About you
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
Requirements

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.
 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

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