Job Description

Role Summary:
The Medical Officer supports medical writing, clinical evaluation, safety surveillance, and regulatory activities for medical devices, ensuring compliance with applicable regulations and contributing to product safety and performance throughout the product lifecycle.

Key Result Areas:

1. Medical Device Medical Writing
Medical Writing - Authoring, updating, and reviewing, medical device focused documents in Regulatory and Safety Space
Clinical Evaluation Plans (CEP)/ Reports (CER)
Post-Market Clinical Follow-Up (PMCF) plans/reports
Clinical Investigation Plan (CIP)/Protocol
Clinical Study Reports (CSRs)
Summaries of Safety and Clinical Performance (SSCP)
Informed Consent Documents (ICD)
Investigators Brochure (IB)
Periodical Safety Update Reports (PSUR)
Publication and white papers
Health Hazard Analysis (HHA) / Evaluation (HHE) or Public Health Threat Analysis (PHTA) for Medical Device complaints
Individual Case Safety Reports Narratives
Other pertinent documents
Literature Science: Literature search strategy, conduct, summary and reports




Preparation of Literature search protocol and search strategy
Conducting systematic literature searches to gather clinical data, evaluating evidence, and extracting data for inclusion in reports
Preparation of Literature summary reports and Literature-based documents such as SotA

2. The Safety Associate for materiovigilance and post-market vigilance
Individual Case Processing: Individual Case Safety Reports (ICSRs) of adverse device incidents and participation in complaint investigations
Medical Coding – DPT Coding and Medical Events Coding
Safety Reporting: Generation of human consequence reports of the complaints reported, which have incidents, near incidents of event of interest or procedural complications etc.
Signal Detection: performing trending analysis, Monitoring Complaints, ADIs, safety literature and databases to identify potential safety risks or recent risks associated with the device.
Fo

📌 Medical Officer (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad