Job Description
Medical Reviewer Qualification: MBBS/MD only (MCI Certification is not mandate) Experience Range: 1 to 7 Years Preferred Experience: Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety) Location: Mumbai/ Pune/ Nagpur/ Gandhinagar/ Bangalore/ Chennai/ Indore. 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 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
💡 Quick Summary
Seeking a career-building opportunity? The Medical Officer Integrated Personnel Services Limited New position is now open for candidates interested in the Health Jobs sector. This role in New Delhi offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
