Post-Market Surveillance & Risk Management Specialist

Job Description

Job Title

Job Description

In this role, you have the opportunity to

Manage activities related to product safety surveillance and risk management including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues. You will serve as a liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E).
You are responsible for

Post Market Surveillance (PMS)

• Ensuring standard PMS processes across business units
• Assuring consistent PMS plans exists for all products
• Assuring consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions)
• Assures consistent PMS Reports across business units

Patient Safety and Regulatory Reporting

• In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
• Assesses product relationship to reported complaint.
• Assures standard regulatory reporting assessment criteria
• Provides input to clinical conclusion to be included in the reports to competent authorities

Risk Management

• Support standard RM processes
• In collaboration with stakeholders, defines standard risk acceptability criteria (RAC) with stakeholders
• Supports the development of consistent RM plans exists for all products
• Assures consistent RM plans exists for all products
• Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations

PMS and RM Governance

• Assures standard PMS and RM governance across Business Units
• Provides oversight of PMS and RM processes and assures standard approach
• Signal Assessment & Escalation:

o Ensures standard statistical trending techniques
o Assesses significant triggers & safety concerns.
o Manage recurrent PMS/RM data review meetings
o Assures standard approach for signal disposition
o Incorporate findings in PMS reports and updated RM files as required

PMS and RM input into Product Development

• Represent PMS interests in multi-disciplinary teams during product development.
• Assures development and completion of PMS & RM deliverables throughout the design process
• Provides input of PMS related product risk & quality issues during the development of new products

You are a part of

The Precision Diagnosis (PD) cluster, specifically within the Magnetic Resonance (MR) Business Unit.

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in health science or similar healthcare-related field, such as Medical Doctor MD, Nursing, Radiology, Registered Pharmacist (RPH) , or equivalent (4 year degree required; additional education is desirable)
• 6-8 years of experience in the pharmaceutical / medical device industry or direct device clinical experience
• Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
• Demonstrates collaborative patient and customer focus
• Direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred.
• Experience interacting with the FDA, ISO, and Other Regulatory Authorities preferred
• English proficiency oral and written must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
• Excellent communications and analytical skills
• Project management skills preferred
• In depth knowledge of medical terminology preferred
• Understanding of statistical fundamentals is preferred
• Experience with health hazard evaluations is preferred

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

• A market conform salary
• 25 Days of leave and the possibility to purchase up to 20 extra days off annually
• A variable bonus based on both Philips results and personal performance
• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
• Solid company pension scheme and attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount
• Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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