Medical Reviewer - Lead
Location: Bengaluru, Chennai, Coimbatore, Gurugram, Hyderabad, Indore, Kochi, Kolkata, Mangaluru, Mumbai, Pune • Level: Senior Level • Openings: 1 • Type: Full-time
Job description
Job Title: Medical Reviewer
Job Location: Pan
India
Work Model: Work from Home
Candidate Expectations
Total
and Relevant Experience – 7 Years to 10 Years
Candidate
Location - Anywhere
Skills
– PSUR, ICSR, Aggregate report, Safety Physician, Medical Review, Signal
Detection
Candidate
Industry (Pharma)
Diversity
– No
Education and Certification
Qualification: MBBS
Specific Remarks: Distance education not accepted.
Certification: NA
Detailed Job Description
Preparation
and review of aggregate reports such as Periodic Benefit-Risk Evaluation
Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk
Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc.
Co-ordination
with various stakeholders to gather data required for Aggregate reports.
Work
closely with service providers and resolve their queries.
Co-ordinate
with various stakeholders internal and external required for the completion
reports.
Preparation
and review of Query responses from Regulatory Authority.
Key Skills
PSUR,
ICSR, Aggregate report, Safety Physician, Medical Review, Signal Detection
Other Specific Remarks
Additional Requirements: Proper
documents for entire career and PF Form 16 Mandatory
Job ID: 2001