Medical Safety Analyst Jobs in Gurgaon - Zyme Pharmaceutical
Job Description
Provide medical experitise on pharmacovigilance services to all Quinties divisions as requested. The Medical Safety Analyst participates in all aspects of Medical Safetys involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
RESPONSIBILITIES
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile.
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data.
- Represent safety and clinical data review findings during client meetings.
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports.
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies.
- Provide medical oversight for label development, review and change.
- Provide medical support and attendance at Data Safety Monitoring Board Meetings.
- Attends and contributes medical safety evaluation on Safety Monitoring Committees.
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document.
- Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments.
- Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.
Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
Job Type: Full-time
Salary: ₹385,000.00 to ₹585,000.00 /year