Post Marketing Surveillance
Senior Specialist

Develop, implement, and maintain the Post Market Surveillance (PMS) system in compliance with regulatory standards and company policies.

Conduct complaint handling, including initiation, investigation, root cause analysis, and documentation of findings.

Perform regulatory reportability assessments and ensure timely reporting of adverse events to appropriate regulatory bodies (e.g., US FDA, EU MDR/MDD, PMDA).

Create and manage PMS plans, PMS reports, Periodic Safety Update Reports (PSUR), and related documentation.

Monitor and analyze post-market data to identify safety signals, trends, and emerging risks, and recommend appropriate actions.

Collaborate with Risk Management, Quality Engineering, and Product Development teams to update risk files based on post-market insights.

Identify and implement Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCAR) when systemic issues are detected.

Prepare reports and presentations for management reviews, regulatory submissions, and audit responses.

Liaise with internal and external stakeholders, including regulatory authorities, auditors, and customers, on PMS-related matters.

Stay up-to-date with changes in global post-market regulatory requirements and implement updates in PMS processes accordingly.