Job Title
Post Market Surveillance Specialist
Job Description
Job Title : Post Market Surveillance Specialist

Job Responsibilities:

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:

• Ensures standard statistical trending techniques

• Assesses significant triggers & safety concerns.

• Manage recurrent PMS/RM data review meetings

• Assures standard approach for signal disposition

• 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
• P

📌 Post Market Surveillance Specialist (Bengaluru)
🏢 Philips
📍 Bengaluru