Clinical Safety Physician

vor 12 Stunden

Lausanne, Schweiz Axepta SA Vollzeit

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

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