Clinical Safety Director
1 month ago
Clinical Safety Director
The Clinical Safety Director is responsible for providing medical leadership across all aspects of medical safety throughout product development and life-cycle management. This role acts across multi-functional teams as a valued individual contributor in providing medical input into all clinical safety related activities, with in-depth expertise in processes for safety assessments & surveillance, complaint analysis & benefit-risk assessments.
Your Role:
- Lead medical safety across various Imaging businesses to enable informed patient-centric decisions.
- Safeguard patient safety through relevant processes including Risk Management, Health Hazard Evaluations (HHE's), Risk-Benefit Analyses, recalls, review of post-market surveillance data to evaluate trends, etc.
- Provide authoritative medical support to R&D, Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, Quality, Risk Management, Legal & Communications.
- Contribute to risk management plans and failure mode analysis during product development, safety signal detection and post-market surveillance post-launch.
- Participate in clinical safety discussions with Key Opinion Leaders (KOLs), regulatory agencies/notified bodies, including during regulatory inspections.
- Provide input into review of applications for Medical and Scientific Information.
Requirements:
- 3+ years of experience in medical safety within the medical device/biotech industry in medical affairs roles.
- Strong background and deep medical expertise in assessment of clinical risk-benefit throughout product development life cycle.
- Deep knowledge and understanding of all applicable standards/regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
- MD or DO degree (required) with relevant experience to imaging medical devices (strongly preferred).
- Ability to travel up to 25%, as required by business needs.
About Philips
We are a health technology company committed to improving people's lives and supporting healthcare practitioners. Our advanced technology and deep clinical and consumer insights focus on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/Connected Care, Sleep & Respiratory Care, and Personal Health. We're dedicated to building a diverse and inclusive workplace culture where people feel heard, valued, and connected.
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