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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%).
- 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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