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Drug Safety Lead (897274-GBA)

CTC Resourcing Solutions

 
Zurich area, Switzerland
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CTC Resourcing Solutions

Providing Flexible Resourcing Solutions

Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

Drug Safety Lead (897274-GBA)

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 client’s Global Drug Safety and Risk Management Team, reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, and you will be responsible to ensure full compliance within the drug safety/pharmacovigilance space.

If you have completed an MD, have at least 3 years of experience in Drug Safety within a biotech/pharmaceutical/CRO company, strong expertise with signal detection and previous experience being accountable for DSURs and SUSARs, then look no further and apply!

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;
  • At least 3 years of 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 Pharmaco-epidemiology;
  • 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.

Address

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

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