Medical Device Physician - Lead

Golden Opportunities; Mumbai, Pune District, Bengaluru; Hybrid; INR 1,200,000 - 2,000,000; Full time

Job summary

Golden Opportunities is seeking an experienced professional for ICSR review and medical device safety assessment, focusing on combination products. The role involves validating ICSRs, reviewing device-related events, and ensuring accurate coding and causality assessments.

The position emphasizes adherence to deadlines, guidance to junior staff, and collaboration with cross-functional teams to support patient safety and regulatory compliance across product life cycles.

Qualifications

• Qualification: Life Science Graduate
• Distance education not accepted.

Responsibilities

• Performs combination products and medical device assessment and validation of ICSR submissions, including review of device-related events and matureness of causality.
• Assesses device complaints for reportability and ensures proper seriousness assessment and device-specific coding.
• Provides justification for reportability or non-reportability per established processes.
• Contributes to process improvements in patient safety and adverse event handling.
• Meets deadlines meticulously and anticipates potential delays to mitigate them.
• Responds to questions on reviewer decisions across functions in a timely manner.
• Mentors new hires and colleagues on review conventions and tools.
• Participates in peer MRQC activities and audits when required.
• Provides medical input to Strategic Operations for case queries.
• Ensures compliance with policies, practices, and regulatory requirements.

Skills

ICSR Review & Validation

Medical Device Safety

Combination Product Assessment

Education

Life Science Graduate

Job description

• Candidate Expectations
• Total and Relevant Experience 5 Years to 7 Years
• 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