17 days ago on ctcon.ch

Drug Safety Manager

CTC Clinical Trial Consulting AG

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 Please refer to JobSuchmaschine in your application

Drug Safety Manager

Reference Number: 189609
Type of placement: Contract
Location: Switzerland, North West


For our pharmaceutical clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.

One of the roles we often recruit for is a Drug Safety Manager. The major goal is to carry out pharmacovigilance activities on a product or group of products. This may include single case medical review, aggregate reporting, signal detection and evaluation, and other safety related activities e.g. associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management.

Main Responsibilities:


  • Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
  • Support the preparation and maintenance of Risk Management plans
  • Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
  • Support the preparation and maintenance of safety sections of the Company Core Data Sheet
  • Lead/support PDS post-marketing safety study activities
  • Coordinate safety activities between PDS and internal and external partners Carry out signal detection activities and evaluation:
  • Conduct/support signal detection and evaluation according to SOPs and guidelines
  • Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)
  • Respond to safety requests  for the assigned product  from regulatory agencies or  affiliates/ other internal functions Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
  • Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
  • Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
  • Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
Qualifications and Experience:

  • Strong knowledge of international drug regulation including GCP, GVP and GMP
  • Experience in drug safety is mandatory
  • Experience with writing and/or reviewing safety sections of periodic safety reports (DSUR, PBRER) and health authority communication, response to questions
  • MD, PhD, PharmD, Pharm, MSc or equivalent qualification
  • Prior industry experience in drug safety, clinical development or medical affairs
  • Good knowledge of pharmacovigilance practices
  • Knowledge of US and/or EU pharmacovigilance regulatory requirements
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
  • Team player with ability to function in a multi-disciplinary environment
  • Fluent in English (verbal and written), any additional language would be an asset
  • Relevant working/residency permit or Swiss/EU-Citizenship required