Sr Medical Reviewer (Aggregate reporting) - Mumbai/Pune/Hyderabad

Sr Medical Reviewer (Aggregate reporting) - Mumbai/Pune/Hyderabad

Stalwart Management Consulting (2 Opening)
1.0 Year(s) To 5.0 Year(s)
0.00 LPA To 0.00 LPA

Job Profile

Sr. Medical Reviewer (Aggregate reporting) - mbbs - 12L  md - 15L

Education- MBBS/MD

Relevant Experience-1 to 2 years

Location- Mumbai/Pune/Hyderabad

Number of positions- 2

JD:

  • 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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