Drug Safety Lead (897274 – SR)

Location
Canton of Zürich (CH)
Salary
negotiable
Posted
12 Feb 2021
Closes
14 Mar 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

We are currently looking for a Drug Safety Lead for a permanent role to be based in Zurich. In this role you will be joining our Global Drug Safety and Risk Management Team. Reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety.

A Medical Degree, combined with experience in Drug safety and Risk Management in a Global environment is essential to qualify for this role.

 Main 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

 Qualifications and Experience:

 ·        Relevant working/residency permit or Swiss/EU-Citizenship required;

  • 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)
  • Capable of exercising oversight in communications and problem solving liaisons with internal and external customers
  • Capable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety development
  • Fluency in English 

Apply for Drug Safety Lead (897274 – SR)

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs