• Contract
  • Suisse Romande
  • Recruiter: Nicola Liversidge

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Senior Drug Safety Physician

Our client is a well-established non-profit drug research and development organisation who partners with private industry, public institutions, academia and NGOs to advance new treatments in disease-endemic countries. 

With a remarkable achievement of bringing 8 new treatments to the market, the organisation also benefits from a rich pipeline of new potential drugs, which are being investigated through their numerous affiliates worldwide.

For their office in Geneva, Switzerland we are looking for a Senior Drug Safety Physician for an initial 12-month contract (70%).

Main Responsibilities:

  • Support the Head of Pharmacovigilance (PV) in ensuring that all Pharmacovigilance-related activities related to the management of clinical studies are performed by trained personnel and compliant with applicable local/international safety reporting requirements
  • Bring medical expertise to drug safety activities for the trials and products assigned to this role. 
  • Subject matter expert in clinical safety data interpretation, clinical safety analysis preparation/ Benefit/risk assessment within periodic safety update reports (together with product/trial medical responsible and PV function Head), or Subject matter expert in signal detection activities, safety risk management activities and safety profile/safety reference information maintenance
  • Subject matter expert in interpretation of regulatory aspects of clinical safety/pharmacovigilance
  • Regular collaboration with other Pharmacovigilance team members and Pharmacovigilance services providers, Clinical Research Organizations (CROs), regional offices and Disease/clinical program leadership
  • Act as Pharmacovigilance Product/Project Responsible (PV PR) for assigned product/project (s); coordinates the Product Safety Monitoring Sub-Team (PSMT) related to assigned product(s)/projects
  • Act as CT Clinical Trial PV Representative(s) (CT PVR) for assigned clinical trials
  • Contribution to the preparation/update of PV standard operating procedures, working instructions and templates

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Medical Doctor Degree
  • Over 8 years in Senior role; minimum 8 years' clinical development experience in which at least 6 years’ demonstrated experience working in clinical safety (within pharmaceutical companies, non-profit organizations or services providers)E
  • Experience of working in public and private sector is highly desirable; experience in tropical/infectious diseases would be welcome
  • Fluency in both French and English are required; proficiency in Spanish, Portuguese or other languages would be welcome
  • Very good knowledge of Microsoft Word, Excel, PowerPoint; MedDRA coding and WHO-DD coding knowledge; Eudravigilance user or XEVMPD certification would be a plus

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