MBBS qualified with relevant Medical Review/ICSR at Senior and Lead positions

MBBS qualified with relevant Medical Review/ICSR at Senior and Lead positions

4-8 years
Not Specified

Job Description

MBBS qualified with relevant Medical Review/ICSR at Senior and Lead positions

Job Title Medical Reviewer / Drug Saftey Associate

Candidates Specification Clinical Experience (or) Pharmacovigilance
 
Educational Qualification MBBS †Both MCI & Non †MCI
 
Exp: Relevant experinece 2-3.5 Years into Clinical or PV domain

Job Description

Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).
Edit the Periodic Report Comment if applicable directly within the Periodic Report Comment field in the Patient Safety database.
Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database:
which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database.
including the narrative.
Provide product advice as required especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).
Review the company causality assessment provided by Medical Advisor.
Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project including the narrative AE/SAE terms suspect drugs concomitant medications laboratory data and medical history.
To provide documentation of the review and case comments in Sapphire in Medical Review workflow.
Maintain knowledge of the marketed drug currently under litigation.
Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff.
Currently: Work from home post pandemic willing to relocate to either Mumbai/Pune/Hyerabad/Coimbatore choice provided


location
Mumbai/ Pune/Hyderabad/Coimbatore
 

UG Qualification
MBBS / MD
 

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