Urgent hiring For Medical Reviewer
- Orion Edutech
- 1 - 5 years
- Multi-City, India
- 2 months ago
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- Pune,Maharashtra, Chennai,Tamil Nadu, Mumbai (All Areas)
Job Description
Role & responsibilities
- 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 the employer, 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.
Preferred candidate profile
- 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
Job Classification
Industry: IT Services & ConsultingFunctional Area: IT Services & Consulting
Role Category: Health Informatics
Role: Medical Record / Health Informatics
Employement Type: Full time
Contact Details:
Company: Orion EdutechLocation(s): Multi-City, India
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Fraud Alert to job seekers!
₹ 12-17 Lacs P.A
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