Medical Safety Manager (all genders)

Job Title

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 postmarket sources and collaborate crossfunctionally to identify assess and mitigate potential safety risks. Your work will play a key role in safeguarding patient wellbeing 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 postmarket surveillance literature reviews and realworld data in accordance with applicable regulatory requirements.

• Analyze safety data from clinical trials and postmarket 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 safetyrelated content for regulatory submissions and key documents such as RiskBenefit Analyses (RBA) Clinical Study Reports (CSR) protocols and Clinical Evaluation Reports (CERs).

• Collaborate with crossfunctional teams during product development and postmarket 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 safetyrelated inquiries from healthcare professionals patients and internal stakeholders ensuring transparent accurate and professional communication regarding product safety.

• Support the implementation and continuous improvement of safetyrelated processes policies and procedures and maintain uptodate knowledge of evolving medical device safety regulations and guidelines.

You Should bring the following

• Bachelors or Masters degree in Medical Science Nursing Clinical Science or an equivalent discipline.

• 35 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 1025% annually for internal and external meetings.

Technical & Functional Skills

• Regulatory Compliance

• Risk Management and RiskBenefit 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 carssmartphones)

• 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

• PhilipsMyShop: 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. Forthisrolethis 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 wewontstop until everybody everywhere has access to thequalityhealthcare that we all patient safety and Quality as our fundamental premise we focus on regulatory requirements and quality standards in our daily the work of your life to help the lives of others.

• Learn more aboutour business.

• Discoverour rich and exciting history.

• Learn more aboutour purpose.

Ifyoureinterested in this role and have many but not all of theexperiencesneeded 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 inclusionhere.

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