Medical Device Physician - Lead - GO/JC/4624/2026

Golden Opportunities

Mumbai

Hybrid

INR 1,200,000 - 1,800,000

Full time

3 days ago
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Job summary

Golden Opportunities is seeking a Medical Device Physician for roles in Mumbai, Pune, or Bangalore. The position supports a hybrid work model with office-based duties and remote collaboration as needed.

The candidate should have 5–7 years of relevant experience in pharma or medical device safety and will evaluate combination products and device safety through ICSR review and validation. The role emphasizes timely responses, adherence to regulatory requirements, and mentorship of newer staff,

Qualifications

  • Must have experience in reviewing and validating ICSRs for combination products and medical devices.
  • Must assess device safety, seriousness criteria, and causality with appropriate documentation.

Responsibilities

  • Perform combination product and medical device assessment and validation of ICSRs, including reviewing device-related complaints.
  • Ensure accurate population of device fields and proper categorization of seriousness and causality.
  • Provide justification for reportability decisions and contribute to PS process improvements.
  • Meet deadlines and communicate findings to other functions promptly.
  • Mentor new hires on review conventions and tools; participate in MRQC activities.

Skills

Medical Device Safety
Combination Product Assessment
ICSR Review & Validation

Education

Life Science Graduate

Job description

Candidate Expectations

Total and Relevant Experience – 5 Years to 7 Years

Job Title

Medical Device Physician

Job Location

Mumbai/Pune/Bangalore

Work Model

Work from Office / Hybrid

Candidate Location

Anywhere

Skills

Medical Device Safety, Combination Product Assessment, ICSR Review & Validation

Candidate Industry

Pharma

Diversity

No

Education and Certification

Qualification: Life Science Graduate

Specific Remarks: Distance education not accepted.

Certification: NA

Detailed Job Description
  • Performs combination products and medical device assessment and validation of individual case safety reports (ICSRs) including reviewing and assessing device complaints (such as device malfunction and usability problems) reportable and or non-reportable complaints by reviewing events (including seriousness criteria and seriousness for device) and coding with causality, and line listings for marketed products and investigational products as applicable.
  • Ensures all device fields are accurately populated and the correct seriousness, seriousness for device, device problem, malfunction, and causality assessment are made.
  • Provides a justification for reportability or non-reportability for the device related events in the case as per the process.
  • Makes contributions to process improvement within Patient Safety (PS), particularly with adverse event processing and operational aspects of medical review as applicable.
  • Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.
  • Responds to combination product and medical device review-related questions from other functions in a timely manner.
  • Mentors and trains new hires and less experienced colleagues on combination product and medical device review conventions and tools as applicable.
  • May perform peer retrospective combination product and medical device review quality control (MRQC) activities and participate in audits.
  • Provides medical input to Strategic Operations on case queries.
  • Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
Key Skills

Medical Device Safety, Combination Product Assessment, ICSR Review & Validation

Other Specific Remarks

Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory

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