Senior Lead Medical Reviewer (Bengaluru)

Senior Lead Medical Reviewer (Bengaluru)

13 Aug
|
Navitas Life Sciences
|
Bengaluru

13 Aug

Navitas Life Sciences

Bengaluru

Job Description

We are currently seeking a Senior/Lead Medical Reviewer with 1 3+ years of Aggregate Reporting, Signal Management, or RMP experience, to join our growing team

Within the role you will:
- Be responsible for the implementation of operational tasks in the field of safety writing
- Oversee service performance
- Mentor employees enabling them to work independently within timelines, budget, and quality
- Review the RMP/PSUR or any aggregate documents for medical cohesiveness
- Manage all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements/expectations
- Develop and dispatch project specific slides for both internal and external parties
- Participate in internal and external audits and inspections by clients and health authorities
- Ensure that all trackers related to Navitas Life Sciences and client specific procedures are in place and up




- Ensure the project team members in completion of all Navitas Life Sciences or client specific training
- Conduct training as required for improvement of team performance
- As required, author and review RMPs, DSUR s, PBRER s, PSUR s, PADER s and Canadian Aggregate Reports
- Provide expertise required for the finalization of the RMPs, DSUR s, PBRER s, PSUR s, PADER s and Canadian Aggregate Reports and its annexes

Resolve issues as they arise

Ensure proper maintenance of all RMPs, DSUR s, PBRER s, PSUR s, PADER s and Canadian Aggregate Reports
- Support in drafting and implementation of Navitas Life Sciences or client specific SOPs or WIs
- Provide inputs in client specific guidance documents
- Acts as Point of contact for our aggregate team and client
- Assist or support the Individual Case Safety Report team as per the workload in respective teams
- Assist or support the Literature review team as per the workload in respective teams
- Assist in the scheduling of reports ass

📌 Senior Lead Medical Reviewer (Bengaluru)
🏢 Navitas Life Sciences
📍 Bengaluru

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