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Medical Reviewer

4 months ago

Mumbai Metropolitan Region, India Integrated Personnel Services Limited Full time

Title:- Medical Reviewer

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

Experience:- 6Years-11Years

Qualification:- 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 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 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 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


Interested candidates can share their CV at prnjal.more@ipsl.co.in