Sr / Lead Medical Reviewer

Navitas Life Sciences Pvt. Ltd.; Bengaluru; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Navitas Life Sciences Pvt. Ltd. in Bangalore, India is seeking an Associate Pharmacovigilance and Safety to support regulatory and safety reporting activities.

You will review RMPs, DSURs, PSURs and related documents, mentor the team, and ensure compliance with client and health authority expectations. Role requires strong pharmacovigilance knowledge, English communication, and ability to work with cross-functional teams. Graduate or postgraduate in Life Sciences or related fields is preferred.

Qualifikationen

• 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.

Aufgaben

• Implement operational tasks in safety writing.
• Oversee service performance.
• Mentor employees to work independently within timelines, budget, and quality.
• Review RMP/PSUR or aggregate documents for medical cohesiveness.
• Manage logistics for timely safety report development and ensure client/authority content requirements.
• Develop and dispatch project slides for internal and external parties.
• Participate in audits and inspections by clients and health authorities.
• Ensure trackers and training are in place and up to date.
• Assist in allocation and tracking of reports within teams.
• Conduct daily status meetings and update SOPs as needed.
• Provide inputs for client guidance documents and act as contact for aggregate team and client.

Kenntnisse

Pharmacovigilance knowledge

GCP/GVP/ICH/USFDA guidelines

Medical terminology

English communication

MS Office

Team mentoring

Ausbildung

Life Sciences / Pharmacy / Medicine degree

Tools

MS Office

Jobbeschreibung

Job Description

• 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 updated on timely basis
• 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.