Senior Medical Safety Manager HPM (all genders)

Job description

Job Title Medical Safety Manager Job Description In this role, you will have the opportunity to ensure patient safety and regulatory compliance across the full product lifecycle for Hospital Patient Monitoring Portfolio by supporting medical product safety surveillance, adverse event reporting, and proactive risk management activities. You will contribute to timely and accurate safety reporting to regulatory authorities and internal stakeholders, analyze safety data from clinical and post‑market sources, and collaborate cross‑functionally to identify, assess, and mitigate potential safety risks. Your work will play a key role in safeguarding patient well‑being and maintaining compliance with global regulatory standards. Your Job Support the timely and accurate evaluation, documentation, and reporting of adverse events from multiple sources, including post‑market surveillance, literature reviews, and real‑world data, in accordance with applicable regulatory requirements. Analyze safety data from clinical trials and post‑market surveillance to identify potential safety signals, trends, and emerging risks, enabling early detection and proactive risk mitigation actions. Assist in the preparation and submission of safety reports and safety‑related content for regulatory submissions and key documents such as Risk‑Benefit Analyses (RBA), Clinical Study Reports (CSR), protocols, and Clinical Evaluation Reports (CERs). Collaborate with cross‑functional teams during product development and post‑market phases to assess safety risks and contribute to the development and implementation of effective risk management strategies. Conduct scientific literature reviews and ongoing safety surveillance activities to identify new or evolving safety issues and ensure continuous compliance with regulatory standards. Respond to safety‑related inquiries from healthcare professionals, patients, and internal stakeholders, ensuring transparent, accurate, and professional communication regarding product safety. Support the implementation and continuous improvement of safety‑related processes, policies, and procedures, and maintain up‑to‑date knowledge of evolving medical device safety regulations and guidelines. You should bring the following Bachelor’s or Master’s degree in Medical Science, Nursing, Clinical Science, or an equivalent discipline. 7-10 years of experience in Medical or Clinical Affairs within the Medical Devices or Biotech industry. Clinical experience in adult or pediatric ICU, operating room, or telemetry environments Willingness and ability to travel internationally approximately 10–25% annually for internal and external meetings. Technical & Functional Skills Regulatory Compliance Risk Management and Risk‑Benefit Analysis Safety Assessment & Surveillance Adverse Event Reporting and Signal Detection Safety Data Analysis and Interpretation Documentation and Regulatory Reporting Scientific Literature Review Strong business and stakeholder communication skills Certified Professional in Patient Safety (CPPS) (Preffered) Philips benefits for you: Annual leave: 30 days Mobility and devices: subsidized Germany ticket, leasing opportunities for private use (bicycles, cars, smartphones,…) Philips University & Philips in Balance: Wide range of professional training courses and for personal development & Healthcare Philips Pension Fund: Employer-funded pension plan “Partnerzeit” – two paid weeks off after your partner has given birth Philips MyShop: Discount on Philips products Free drinks and low prices in our canteen and Café Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc. How We Work Together We believe that we achieve better results when we work together rather than apart. For this role this means to be on-site at least 3 days a week. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. • Learn more about our business . • Discover our rich and exciting history . • Learn more about our purpose . If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here . #LI-EU