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Global Medical Director for Patient Safety and Risk Management
hace 2 meses
At Sin Nombre, we are seeking a highly skilled and experienced Medical Director to lead our Global Patient Safety and Risk Management efforts. As a key member of our team, you will be responsible for executing safety and risk management activities for our clinical development projects and marketed products.
Key Responsibilities- Lead risk management evaluation and resolution for assigned products and projects.
- Identify potential signals for observed adverse events for further review and analysis.
- Direct the Safety Management Team for the assigned project(s) or product(s), ensuring a safety and risk/benefit driven agenda from inception to closure.
- Represent GPV on other project/product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings, and other risk mitigations.
- Collaborate with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals.
- Detect, validate, and manage pre- and/or post-approval safety signals through to resolution.
- Ensure timely, accurate recording of risk management action plans and decisions.
- Conduct medical assessment of causality of Individual Case Safety Report (ICSR) as necessary.
- Evaluate aggregate safety data and write contributions to its interpretation for various safety and risk/benefit evaluations.
- Provide medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-making.
- Identify, initiate, and manage necessary updates to labeling documentation.
- Conduct medical evaluation of issues arising from PV Operations.
- Provide medical input to ARGUS search criteria as necessary.
- MD Required
- Five years relevant safety and risk management experience in the pharmaceutical industry
- Knowledge and understanding of PV deliverables, standards, and processes
- Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic/product area(s)
- Excellent, independent judgment based on leading-edge knowledge and expertise
- Strong verbal and written communication skills
- Sound problem-solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
- Ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines
- 4+ years in clinical medicine (post-training/residency)
- Rare, Ultra-Rare or Orphan Disease Area experience
- Strong personal time-management and project-management skills
- Collaborative skills to partner with internal and external teams
