Vacancy description
zydus group
India, Ahmedabad
Health & Medical Officer in Ahmedabad, India is listed on Jobeax. Browse 30,000+ vacancies available.
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 new risks associated with the device.
Follow-up: Communicating with healthcare professionals to gather additional information on adverse events.
3. Organizational responsibilities
Regulatory Compliance: Ensuring all documents adhere to India MDR, EU MDR, ISO 13485, other regulatory requirements and company's standard operating procedures (SOPs).
Collaboration: Working with Regulatory Affairs, Quality, and R&D teams to align clinical data with safety and performance requirements.
Required Qualifications & Skills:
Education: Medical Graduation – only MBBS or BHMS candidates may apply. Exceptionally good Pharm D candidates who have exposure and understanding of Medical Devices may be considered.
Experience: 0-3 years of experience in Medical Devices Safety Functions or Medical Writing
Knowledge: Deep understanding of EU MDR requirements, literature search methodologies, and clinical data interpretation.
Skills: Exceptional writing/editing skills, Proficiency in English, understanding of French / Portuguese is an added advantage attention to detail, and proficiency in MS Office (Word/Excel), strong analytical thinking
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