Medical Safety Director - Enterprise Informatics
About The Position
Medical Safety Director, Enterprise Informatics The Enterprise Informatics Business portfolio connects clinical informatics, data management and interoperability to deliver improved clinical insights to health care providers. The Medical Safety Director will pioneer comprehensive safety evaluations and risk management strategies, optimizing product efficacy and ensuring patient safety. By staying at the forefront of safety science and regulatory advancements, you will shape the future of medical innovation and empower our team through insightful training and knowledge sharing.
Requirements
- 8+ years of related medical safety experience with a bachelor's degree OR 6+ years with master's degree or higher. Prior people leadership experience preferred.
- Strong background and deep medical expertise in assessment of clinical risk-benefit throughout the product development life-cycle
- Deep knowledge and understanding of all applicable standards and regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
- Experience leading medical input into critical business decisions regarding potential patient safety issues.
- Ability to perform analysis and interpretation of signals & trends from multiple inputs including clinical data, literature, complaints etc.
- Bachelor's/Master's Degree in Medical Science, Nursing, or equivalent; MD Preferred.
- Ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- Excellent communicator (verbal and written) and have strong interpersonal skills as required for cross-functional collaboration.
- Proven ability to be a strong advocate for patient-centric decision making and are adept at anticipating changing priorities and demands to address them proactively.
Nice To Haves
- CPPS certification strongly preferred.
Responsibilities
- Ensures patient safety by offering medical expertise in Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit Analyses (RBA), and recall procedures.
- Provides essential input into safety-related sections of regulatory submissions and pertinent documents, including protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CER).
- Acts as a medical expert, offering safety insights for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) Initiatives.
- Conducts comprehensive evaluations of safety information sourced from Post-Marketing Surveillance (PMS) and literature searches to ensure a thorough understanding of potential risks and benefits.
- Provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product life cycle.
- Contributes to the development and review of safety related documents, including risk management plans, safety reports, and regulatory submissions.
Benefits
- Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
