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,- 00 - 2,000,000.00 per year
Jadwal: - Day shift
Morning shift
Rotational shift
Tunjangan: Provident Fund
Upah Tambahan:
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
