Role & responsibilities

- Support the development and maintenance of Post-Market Surveillance (PMS) plans, reports, and related documentation.
- Collect, review, and analyze clinical, complaint, vigilance, adverse-event, and product-safety data.
- Identify safety signals, emerging risks, adverse trends, and gaps in clinical evidence.
- Conduct clinical literature searches and reviews related to product safety and performance.
- Support Post-Market Clinical Follow-up (PMCF) activities, reports, and Periodic Safety Update Reports (PSURs).
- Evaluate clinical evidence against product claims, intended use, known risks, and expected benefits.
- Provide clinical input to complaint investigations, adverse-event assessments, and escalation decisions.
- Support benefit-risk assessments and updates to Clinical Evaluation, Risk Management, labeling, and regulatory documentation.
- Collaborate with Clinical, Quality, Regulatory, Vigilance, Complaint Handling, Risk Management, and Engineering teams.
- Maintain accurate, traceable PMS records and support audits,



inspections, and regulatory submissions.
- Prepare clinical summaries, reports, presentations, and other project deliverables within established timelines.

Preferred candidate profile

- 10+ years of experience in Clinical Affairs, Post-Market Surveillance, Clinical Evaluation, Medical Safety, or related medical-device functions.
- Strong experience with medical-device PMS, clinical evaluation, complaint/vigilance data, and safety assessment.
- Experience with clinical literature review, clinical-data analysis, and scientific documentation.
- Knowledge of medical-device regulatory requirements, risk management, benefit-risk assessment, and safety-signal evaluation.
- Robust analytical, scientific-writing, documentation, and communication skills.
- Ability to work effectively across Clinical, Quality, Regulatory, Medical, and Engineering functions.

📌 Senior Clinical Post-Market Surveillance Specialist (India)
🏢 Tekone It Services
📍 India