Sr Medical Reviewer (Aggregate reporting) - Mumbai/Pune/Hyderabad
Sr. Medical Reviewer (Aggregate reporting) - mbbs - 12L md - 15L
Relevant Experience-1 to 2 years
Number of positions- 2
- Ensuring the Periodic safety Update Report (PSUR) is medically relevant, complete, consistent and accurate
- Causality assessment and writing medical assessment comment
- Review and finalize narratives
- Ensuring that the safety issues are adequately addressed in the aggregate document
- To discuss and provide analysis for correct review period and cumulatively, including adverse drug reactions reported spontaneously and published literatures
- To review and provide any noteworthy findings for the current review period
- To review and provide medical comments for published studies including pregnancy registries
- To discuss and provide analysis for drug interactions, overdose, drug abuse/misuse, pregnancy/lactation, special patient groups and medication errors
- To provide the final conclusion regarding the current safety profile of the product
- Responding to medical queries raised by the client Single Point of Contact (SPOC) and provide feedbacks
- Reporting to team manager on performance, status and any escalations
Roles & Responsibilities :-
- Bachelor’s degree in Medicine, i.e., MBBS, equivalent US MD.
- Understanding of Drug Safety, processing of serious and non-serious advents preferred.
- A minimum of 2 years oncology experience in Pharmaceutical industry or in clinical setting (including experience in hospitals, nursing homes, clinics ) is preferred.
- 6 months experience in PV medical review is required
- Working knowledge of ICH, Good Clinical Practices, investigational and post marketing regulatory guidelines is preferred.
- Effective communication, organization and time management skills.
- Ability to work independently under tight time constraints
- Good interpersonal skills and the ability to operate effectively in an international environment
- Background in clinical sciences is preferred
- English language (written proficiency) preferred.
- Computer proficiency and ability to work in specific databases
P.S: MCI registration is not mandatory. We can consider even if they don’t have MCI registration, however preference should be given to MCI registered candidates.
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