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Senior/Lead Medical Reviewer

3+ years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior/Lead Medical Reviewer

Job Overview

We are seeking a Senior/Lead Medical Reviewer with 1–3+ years of experience in Aggregate Reporting, Signal Management, or RMP. This role involves oversight of safety report development, mentoring team members, ensuring compliance with regulatory guidelines, and maintaining high-quality pharmacovigilance deliverables.


Key Responsibilities

Operational & Review Tasks

  • Implement operational tasks related to safety writing.

  • Review RMPs, PSURs, DSURs, PBRERs, PADERs, and Canadian Aggregate Reports for medical cohesiveness.

  • Manage logistical aspects for timely development of safety reports.

  • Ensure content meets client and Health Authority expectations.

  • Develop and dispatch project-specific slides for internal and external stakeholders.

  • Ensure trackers for Navitas Life Sciences and client-specific procedures are updated timely.

  • Author and review aggregate documents as required.

  • Support drafting and implementation of SOPs or Work Instructions (WIs).

  • Provide expertise in finalization of aggregate reports and resolve arising issues.

Team Leadership & Mentoring

  • Mentor team members to work independently within timelines, budgets, and quality standards.

  • Conduct training sessions to improve team performance.

  • Support workload distribution and scheduling within the team.

  • Conduct daily status meetings as required for projects.

  • Ensure compliance of the team in delivering high-quality reports.

Cross-Functional Support

  • Act as a point of contact for the aggregate team and clients.

  • Assist Individual Case Safety Report (ICSR) and Literature Review teams as needed.

  • Provide inputs for client-specific guidance documents.

  • Assist manager in allocation and tracking of team deliverables.


Required Skills & Experience

  • 1–3+ years experience in Aggregate Reporting, Signal Management, or RMP.

  • Good understanding of medical and pharmacovigilance terminologies.

  • Knowledge of GCP, GVP, ICH, USFDA, and other relevant pharmacovigilance regulations.

  • Basic competence with medical and therapeutic terminology.

  • Understanding of patient safety regulatory obligations and pharmacovigilance guidelines.

  • Strong command of written and spoken English; additional languages are a plus.

  • Proficiency in MS Office (Word, Excel, PowerPoint).

  • Soft skills: motivation, strong communication, structured work approach, organizational skills, reliability, commitment, and team collaboration.


Why Join Us

  • Work in a global organization focused on patient safety and pharmacovigilance excellence.

  • Opportunity to mentor teams and lead critical safety reporting projects.

  • Contribute to ensuring compliance with regulatory and client standards.

  • Grow professionally within a collaborative, structured, and supportive environment.