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COD Research, a leading clinical research organization, is hiring a Medical Safety Executive in Ahmedabad, Gujarat. This role focuses on Pharmacovigilance and Materiovigilance for medical devices and drug-device combination products. If you are skilled in clinical evaluation, safety reporting, and regulatory compliance for EU/US markets, this is your opportunity to advance your career in patient safety and medical device regulations.
Key Responsibilities
As a Medical Safety Executive, you will:
- Create and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF Plans, PMCF Reports, and SSCP for medical devices per MEDDEV, MDD, and EU MDR guidelines.
- Prepare and maintain PMS documents including PMS Plan, PMS Reports (PMSR), PSUR, and Risk Management Files for medical devices and combination products.
- Draft and update Aggregate Safety Reports such as PADERs, PSURs, and RMPs for drug-device combination products.
- Generate applicable line listings from safety databases and perform literature screening for relevant cases.
- Review case reports and Adverse Outcomes of Interest (AOIs) from literature and regulatory sources.
- Participate in audits and regulatory inspections, providing required documentation and support.
- Develop, review, and update SOPs, Work Instructions (WIs), guides, and training materials.
- Perform other tasks as assigned by management.
Qualifications & Experience
- Scientific degree required; advanced degrees like M. Pharm, PharmD, or PhD preferred.
- 3–4 years of experience in Pharmacovigilance (PV) or Materiovigilance (MV).
- Experience with medical terminology and multiple product types such as vaccines, cell and gene therapies, or medical devices.
- Familiarity with EU/US regulations, including ICH, GVP, MDR.
- Experience in biopharmaceutical or medical device companies preferred.
Benefits
- Competitive salary and performance incentives
- Exposure to global regulatory standards and audits
- Opportunity to work with innovative drug-device combination products
- Professional development and training programs
- Dynamic and supportive work environment
Estimated Salary: ₹6,00,000 – ₹9,00,000 per year (INR)
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How to Apply
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