JOB DESCRIPTION
Job Title
Medical Safety Manager (all genders)
Job Description
In this role, you will have the opportunity to ensure patient safety and regulatory compliance across the full product lifecycle 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
1. 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.
2. 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.
3. 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).
4. 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.
5. Conduct scientific literature reviews and ongoing safety surveillance activities to identify new or evolving safety issues and ensure continuous compliance with regulatory standards.
6. Respond to safety‑related inquiries from healthcare professionals, patients, and internal stakeholders, ensuring transparent, accurate, and professional communication regarding product safety.
7. 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
8. Bachelor’s or Master’s degree in Medical Science, Nursing, Clinical Science, or an equivalent discipline.
9. 3–5 years of experience in Medical or Clinical Affairs within the Medical Devices or Biotech industry.
10. Clinical experience in adult or pediatric ICU, operating room, or telemetry environments
11. Willingness and ability to travel internationally approximately 10–25% annually for internal and external meetings.
Technical & Functional Skills
12. Regulatory Compliance
13. Risk Management and Risk‑Benefit Analysis
14. Safety Assessment & Surveillance
15. Adverse Event Reporting and Signal Detection
16. Safety Data Analysis and Interpretation
17. Documentation and Regulatory Reporting
18. Scientific Literature Review
19. Strong business and stakeholder communication skills
20. Certified Professional in Patient Safety (CPPS) (Preffered)
Philips benefits for you:
21. Annual leave: 30 days
22. Mobility and devices: subsidized Germany ticket, leasing opportunities for private use (bicycles, cars, smartphones,…)
23. Philips University & Philips in Balance: Wide range of professional training courses and for personal development & Healthcare
24. Philips Pension Fund: Employer-funded pension plan
25. “Partnerzeit” – two paid weeks off after your partner has given birth
26. Philips MyShop: Discount on Philips products
27. Free drinks and low prices in our canteen and Café
28. 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. With patient safety and Quality as our fundamental premise, we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others.
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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 commitment to diversity and inclusion.
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