31 Oct
|
Golden Opportunities
|
India
31 Oct
Golden Opportunities
India
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 Advantage-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
📌 Medical Reviewer Lead Chennai (India)
🏢 Golden Opportunities
📍 India