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 company , 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

Job Types: Full-time, Permanent

Pay: ?1,500,000.00 - ?2,000,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift
• Morning shift
• Night shift
• Rotational shift

Supplemental pay types:

• Yearly bonus

Application Question(s):

• Qualified MBBS/MD? Yes or No

Experience:

• Medical Reviewer: 8 years (Preferred)
• clinical comment: 6 years (Preferred)
• Suspected Unexpected Serious Adverse reaction comments: 7 years (Preferred)
• medical product advice: 5 years (Preferred)
• Drug Safety and Regulatory process: 7 years (Preferred)
• MS Office: 7 years (Preferred)

Work Location: In person