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Drug Safety Lead - Switzerland (BB-12AF7)

Gefunden in: Neuvoo Premium CH

Beschreibung:
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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