Medical Reviewer

1 week ago


Mumbai, Maharashtra, India Integrated Personnel Services Limited Full time

Title:

  • Medical ReviewerLocation:
  • Pune/ Bangalore/ Chennai/ Nagpur/ Indore/Gandhinagar/MumbaiExperience:
  • 6Years-11YearsQualification:
  • MBBS/ MD with clinical or non-clinical exp, PV, Clinical Trials & ICSR, SUSAR

Job Description:

  • Author a company clinical comment (CCC) for case reports that are Suspected UnexpectedSerious Adverse reaction (SUSAR).
  • Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Commentfield in the Patient Safety database.
  • Perform the following actions within the Comments field of the GSP Review Workflow step inthe Patient Safety database:
  • Review and respond to any queries/comments from the Case Owner, which are recorded in theComment field of the GSP Review Workflow step in the Patient Safety database.
  • Detail any requests for changes to the case, including the narrative.
  • Detail any follow
  • up information that is required and not already noted within the QueryManager in the Patient Safety database.
  • Provide product advice as required, especially with regards to case reports that are SuspectedUnexpected 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 ofthe drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitantmedications, laboratory data, and medical history.
  • To provide documentation of the review and case comments in Sapphire in Medical Reviewworkflow.
  • Ensure compliance with global and local procedural documents and local implementation ofclient and TCS, policies, procedures and processes.
  • Maintain knowledge of the marketed drug currently under litigation.
  • Maintain knowledge of the company disease and therapeutic areas for marketed drugs anddrugs in development through periodic medical review training held by client medical staff.

Skills required:

  • Computer Literate (good knowledge of MS Office)
  • Sound understanding of the Drug Safety and Regulatory process
  • Good problem solving and decision-making skills
  • Capability to lead by motivation and example
  • Ability to prioritize schedule and organize
  • Excellent interpersonal and communication skills
Interested candidates can share their CV at
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