Medical Officer

1 week ago

Mumbai, Maharashtra, India Integrated Personnel Services Limited Full time
Role -Medical Reviewer Qualification: MBBS/MD only (MCI Certification is not mandate**)

Experience Range: 1 to 7

Years Preferred Experience:
Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety)

Location:
Mumbai/ Pune/ Nagpur/ Gandhinagar/ Bangalore/ Chennai/ Indore

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: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment 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 Query Manager in the Patient Safety database.
  • 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.
  • Ensure compliance with global and local procedural documents and local implementation of client and 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 and drugs 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

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