Drug Safety Lead - Switzerland job in Zürich, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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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