Medical Reviewer
1 week ago
Title:
- Medical ReviewerLocation:
- Pune/ Bangalore/ Chennai/ Nagpur/ Indore/Gandhinagar/MumbaiExperience:
- 6Years-11YearsQualification:
- MBBS/ MD with clinical or non-clinical exp, PV, Clinical Trials & ICSR, SUSARJob 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 skillsInterested candidates can share their CV at
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Medical Reviewer
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