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P2306 - Clinical Operations Transparency Lead
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Pae6 - Trainee Clinical Trial Coordinator - 12
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Clinical Safety Physician
vor 2 Wochen
My client, a global and growing pharmaceutical company located in Vaud or Zug canton is looking for his new position for a Clinical Safety Physician to join his team. This position will be a strategic position at a global level.to ensure that the benefit risk assessment is current for a specific set or category of their products **YOUR RESPONSIBILITIES**: - Ensure measures aiming at minimizing risks during clinical development; - Provide and update the Development Risk Management Plans - Be the point of contact with internal and external stakeholders to ensure monitoring of safety profile and propose appropriate risk management and risk minimization measures - Lead input to Aggregate Reports (e.g. DSUR, PSUR, PBRER) and Risk Management Plans - Ensure to answers to safety-related questions for safety-related aspects/questions; and Due Diligences, as needed with Regulatory agencies and internal/external stakeholders; Investigators/KOLs meetings - Lead on-going safety data review during clinical trials through Safety Plans and Safety Review Meetings - Ensure effective collaboration with the Strategy & Innovation Group, Clinical Development group, and the other stakeholders - Provide guidance and medical support to the safety scientists in charge of case processing, without direct reporting line **YOUR PROFILE**: - Medical Degree (M.D.) + additional degree in clinical pharmacology and/or pharmacovigilance/drug safety is required - Minimum 10 years experience of pharmacovigilance experience in pharmaceutical/medical device companies at a global/international level - Strong experience and understanding of international clinical development and post marketing regulations applicable to drugs; knowledge of medical devices requirements is a bonus; - Interactions with Health Authorities in the US, EU and other geographies to address medical safety questions related to safety in clinical studies (e.g. Summary of Clinical Safety, Clinical Overview, RMP); - Significant late-phase clinical development experience, especially with regulatory filings such as NDA, BLA, MAA, NDS - Experience in analysing and managing significant safety issues across product life cycle with a focus on pipeline drugs in clinical development - Ability to identify risks and propose mitigation actions in complex and critical situations and the ability to influence a cross-functional team and achieve deliverables within agreed timelines - Ability to manage ambiguity and ‘conditional' problem solving - Fluent in English language - Proficient in MS Office (Excel, Word, PowerPoint, Outlook, Teams) - Proficient in eDocument Management, PV computerized systems