Medical Safety Manager – Enterprise Informatics

About the role

The Medical Safety Manager, Enterprise Informatics (EI) conducts comprehensive evaluations of safety information from various channels such as Post‑Marketing Surveillance and literature searches, working under limited supervision. The role supports patient safety by providing insights for risk management, health hazard evaluations, risk‑benefit analyses and recall procedures.

Key responsibilities

• Provide safety insights for risk management, health hazard evaluations, risk‑benefit analyses and recall processes.
• Assist safety perspectives for New Product Introduction projects, clinical studies and post‑marketing surveillance efforts.
• Collaborate to supply safety inputs for regulatory submissions, including risk‑benefit analyses, protocols, clinical study reports and clinical evaluation reports.
• Conduct literature reviews and surveillance activities to identify emerging safety issues.
• Respond to safety‑related inquiries from healthcare professionals, patients and internal stakeholders.
• Contribute to the development and implementation of safety policies, procedures and programs.
• Provide input into the design and conduct of safety studies and medical device vigilance activities.
• Analyze safety data from clinical trials and post‑market surveillance to detect signals and trends.

Required profile

• 7+ years of experience in medical/clinical affairs within the medical device or biotech industry.
• Active clinical license (Nursing or MD preferred).
• Bachelor’s or Master’s degree in a medical, nursing or related field (MD preferred).
• Strong knowledge of medical device standards and regulations (ISO, IEC, etc.).
• Proficiency in health hazard evaluations, issue impact assessments and risk‑benefit analyses.
• Excellent communication skills with the ability to influence cross‑functional stakeholders.

Required skills

• Knowledge of ISO and IEC medical device standards.
• Experience conducting health hazard evaluations, issue impact assessments and risk‑benefit analyses.
• Clinical data analysis for safety signal detection.

What we offer

• Comprehensive Philips Total Rewards benefits program, including generous PTO, 401k with up to 7% match, HSA contributions, stock purchase plan and education reimbursement.
• Competitive salary range ($133,000 – $237,000 USD per year) with potential annual incentive bonus and long‑term incentives.
• Opportunities to work on innovative health‑technology projects that improve patient outcomes worldwide.