Lead - Medical Reviewer

Found in: beBee S IN - 3 weeks ago


Mumbai, India Cognizant Technology Solutions Full time

Aggregate report medical reviewer:

 

Job description:

-        Attend Kick-off meeting organized by aggregate report writers to understand overall timeline requirements

-        Provide safety inputs at kick-off meeting by reviewing various documents (e.g. Previous aggregate report, labelling document, RMP, Health Authority Assessment Reports etc)

-        Works with aggregate report author to decide strategy of aggregate report and search criteria for various safety topics to be presented in the PSUR

-        Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements

-        Perform analysis and medical review of safety data as per regulatory requirements for aggregate report

-        Ensure the analysis and conclusions drawn are medically relevant, complete, consistent, and accurate.

-        Address comments from Peer reviewer or independent quality reviewer on assessment presented or strategy deployed, ensuring that all client and regulatory requirements for quality are met

-        Address comments received on medical assessment or analysis from different stakeholders including client safety physician or QPPV

-        Provides inputs into responses to inquiries from regulatory authorities on safety issues.

-        Contributes to safety and pharmacovigilance training programs.

-        Training and mentoring of other aggregate reports safety physicians

-        Any other activity based on client request

Experience:

-        Minimum 2-3 years of experience in drug safety domain, of which minimum 1 years of experience in aggregate report reviewing

Qualification:

-        MBBS/MD


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