Medical Device Physician - Lead
Location: Pune, Bengaluru, Mumbai
• Experience: Mid Level
• Openings: 2
Job description
Job Title: Medical
Device Physician
Job Location: Mumbai/Pune/Bangalore
Work Model: Work from Office / Hybrid
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