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NAVITAS LIFE SCIENCES
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Senior Lead Medical Reviewer

Senior Lead Medical Reviewer

NAVITAS LIFE SCIENCES

3 - 8 years

4 - 8 Lacs

bengaluru

Posted:3 weeks ago| Platform:

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Skills Required

gcp pharmacy clinical development senior lead scheduling life sciences pharmacovigilance operations ms office word clinical data

Work Mode

Work from Office

Job Type

Full Time

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 assigned to the team

Assist Manager/designee in allocation, tracking of reports developed by the team

Conduct daily status meetings as required for the projects

Support in creating/ updating SOPs as required

Ensure team compliance in delivering the reports

Desirable Skills and Experience

Good understanding of medical and Pharmacovigilance terminologies

Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations

Basic competence with medical and therapeutic terminology

Understanding of patient safety regulatory obligations

Should be familiar with regulatory and pharmacovigilance guidelines

Good command of written and spoken English; additional languages favourable

Good knowledge of usual office software (MS Office: Word, Excel, Power point)

Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability commitment and capacity for team work)

Bangalore, India

Graduate or Post-Graduate in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, and any additional related courses

Associate

Pharmacovigilance and Safety

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