Drug Safety Lead - Switzerland

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. Switzerland
Zürich, Switzerland
Posting date: 11 Feb 2021
35628

A vacancy has arisen for Drug Safety Lead in Switzerland at a large pharmaceutical company. Your role will oversee compliance of company drug safety.

Job Responsibilities

  • Manage the review of worldwide reports on adverse events including confirming company causality assessments
  • Manage the timely authoring of high quality aggregate safety reports
  • Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documents
  • Support safety trainings for new staff, pharmacovigilance staff as well as refreshers
  • Implementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc.
  • Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations
  • Provide support in checking or preparing expert reports as appropriate and preparing safety regulatory files
  • 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
  • Active involvement in PASS or other safety studies
  • Creation/authoring of Medical / Clinical Safety related SOPs

Skills and Requirements

  • Medical Degree, ideally Specialist in Internal Medicine or Pharmaceutical Medicine
  • 3-5 years' experience in the pharmaceutical industry
  • Experience in data analysis, signal detection and benefit/risk evaluation
  • Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)
  • Experience in Pharmaceutical Medicine, particularly Clinical Research, Clinical Pharmacology, and Pharmacoepidemiology
  • Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues
  • Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
  • Good computer literacy with experience with safety data bases (ArisG preferably)
  • Fluency in English

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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