DirecciónAggregate report Medical Reviewer:
Job description:
- Attend Kick-off meeting organized by aggregate report writers to understand overall timeline requirements
- Provide safety inputs at kick-off meeting by reviewing various documents (e.g. Previous aggregate report, labelling document, RMP, Health Authority Assessment Reports etc)
- Works with aggregate report author to decide strategy of aggregate report and search criteria for various safety topics to be presented in the PSUR
- Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements
- Perform analysis and medical review of safety data as per regulatory requirements for aggregate report
- Ensure the analysis and conclusions drawn are medically relevant, complete, consistent, and accurate.
- Address comments from Peer reviewer or independent quality reviewer on assessment presented or strategy deployed, ensuring that all client and regulatory requirements for quality are met
- Address comments received on medical assessment or analysis from different stakeholders including client safety physician or QPPV
- Provides inputs into responses to inquiries from regulatory authorities on safety issues.
- Contributes to safety and pharmacovigilance training programs.
- Training and mentoring of other aggregate reports safety physicians
- Any other activity based on client request
Experience:
- Minimum 2-3 years of experience in drug safety domain, of which minimum 1 years of experience in aggregate report reviewing
Qualification:
- MBBS/MD
Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Feb 27 2024
About Cognizant
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
