Role & responsibilities:
- Support the development, execution, and maintenance of Post-Market Surveillance plans and activities.
- Collect, review, and analyze clinical, safety, performance, complaint, vigilance, and field data.
- Evaluate complaints, adverse events, clinical trends, and other post-market information for potential safety signals.
- Conduct literature searches and assess published clinical evidence related to product safety and performance.
- Support the preparation and maintenance of Post-Market Clinical Follow-up (PMCF) plans and reports.
- Support preparation of Periodic Safety Update Reports (PSURs) and other PMS deliverables.
- Evaluate clinical evidence against product claims, intended use, known risks, and expected advantages.
- Identify emerging risks, safety trends, evidence gaps, and potential escalation concerns.
- Support benefit-risk assessments and updates to clinical evaluation and risk-management documentation.
- Provide clinical input to complaint investigations, potential adverse-event assessments, and escalation decisions.




- Support updates to Clinical Evaluation Reports, risk-management files, labeling, and regulatory documentation.
- Partner with Quality, Regulatory Affairs, Clinical Affairs, Complaint Handling, Vigilance, Risk Management, and Product Engineering teams.
- Maintain accurate, complete, and traceable PMS documentation in accordance with internal procedures.
- Support regulatory submissions, audits, inspections, and responses related to post-market clinical activities.
- Prepare clinical summaries, reports, presentations, and project updates for stakeholders.
- Complete assigned PMS and clinical-remediation activities within established timelines.

Preferred candidate profile
- 10+ years of experience in Clinical Affairs, Post-Market Surveillance, Clinical Evaluation, Medical Safety, or a related medical-device function.
- Proven experience supporting PMS activities within the medical-device industry.
- Experience revi

📌 Clinical PMS Specialist (India)
🏢 Tekone It Services
📍 India