Senior Medical Safety Manager HPM (all genders)

• Job Title
• Senior Medical Safety Manager HPM (all genders)

Job Description

In this role, you will have the opportunity to ensure patient safety and regulatory compliance across the full product lifecycle for the 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.

Key Responsibilities

• 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.

Qualifications

• 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.
• 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

Certifications

Certified Professional in Patient Safety (CPPS) – Preferred

Benefits

• Annual leave: 30 days
• Mobility and devices: subsidized Germany ticket, leasing opportunities for private use (bicycles, cars, smartphones, …)
• Philips University & Philips in Balance: professional training courses and personal development opportunities
• Philips Pension Fund: employer‑funded pension plan
• Partnerzeit – two paid weeks off after your partner has given birth
• Philips My
• Shop: discount on Philips products
• Free drinks and low prices in the canteen and café
• Informal culture, a paid day for voluntary work, team and cultural activities on sustainability and diversity
• Work Arrangement

For this role, you are required to be on-site at least 3 days a week.

Equal Employment Opportunity

Philips is an equal‑employment‑opportunity employer.

We provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability, ethnicity, gender identity or expression, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other protected class.

For U.

S. applicants, Philips is an affirmative action employer and provides reasonable accommodation to individuals requiring assistance in the application process.

If you have an individualized need for reasonable accommodation, contact 888‑367‑7223, option 5.

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