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Philips PMS & RM Specialist India, Maharashtra 50539339
PMS & RM Specialist
Your role:
You are responsible for managing 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.
Serves 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).
Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Reviews complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
Post Market Surveillance (PMS)
• Ensures standard PMS processes across business units.
• Assures consistent PMS plans exists for all products.
• Assures 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're the right fit if:
- Bachelor’s degree with min. 8 Yrs. of experience.
- Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulations, Canadian Medical Devices Regulations (SOR/98-282), and Japanese MHLW Ordinance 169.
- Good Verbal and written communication skills.
- Analytical skills and focus on detail.
- Teamwork in and outside Q&R.
- Fluent in English (verbal and written).
- Product Knowledge is preferred.
- Medical Device and or other regulated industry (e.g. Pharma, IVD) is preferred.
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.
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