Drug Safety Lead – Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Drug Safety/Pharmacovigilance

Firma: OM Pharma

Darya Koblik

International Talent Acquisition Specialist

+41 58 851 89 22

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Ihr Profil

We are currently looking for an Drug Safety Lead who will be based at our OM Pharma site in Geneva to support drug safety activities of the OM pharma portfolio. Your responsibilities will include, but not be limited to:
  • Managing the review of worldwide reports on adverse events including confirming causality assessments
  • Managing the timely authoring of high quality aggregate safety reports
  • Creation and update of Risk Management Plan, implementation of additional PV activities or risk minimisation measures
  • Active involvement in PASS or other safety studies
  • Signal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plans
  • Supporting regulatory department with evaluation of adverse event profile of product to update regulatory documents
  • Ensuring safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations
  • Supporting safety trainings for new staff, pharmacovigilance staff as well as refreshers
  • Review of Medical / Clinical Safety related SOPs
The ideal candidate is bringing the following experience:
  • Medical Degree with 2-5 years of medical clinical practice or PhD/equivalent with experience in International Drug Safety (ideally operational as well as clinical drug safety)
  • 2-4 years of experience in Pharmacovigilance
  • Experience in data analysis, signal detection and benefit/risk evaluation
  • Excellent knowledge of international regulations (ICH, GVP/EU, FDA regulations)
  • Very good scientific, pharmaceutical and medical knowledge. Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology is preferred. Knowledge and experience in Pharmacoepidemiology is an advantage. Ability to interpret and apply global drug safety regulations
  • Fluency in English
  • Ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues is an advantage
  • Proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
  • Good computer literacy with experience with safety data bases (Aris G preferably)
You show concern for standards, you are thorough and attentive to details. You think and influence conceptually, strategically and rationally and have excellent analytical skills. You have excellent verbal and written communication skills. You show initiative and ability to plan and prioritise workload and demonstrate proactive problem-solving approach. You are effectively working in cross-functional environment with many partners. You are a team player with a positive attitude and act as a role model for others, in line with the Vifor Pharma Group Values.

Über uns

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.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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