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Senior/Lead Medical Reviewer

1-3 years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 – Pharmacovigilance | Navitas Life Sciences

Job Summary:
Navitas Life Sciences is hiring a Senior/Lead Medical Reviewer with 1–3+ years of experience in aggregate safety reporting, signal management, and Risk Management Plans (RMPs). This pivotal pharmacovigilance role involves end-to-end medical review and oversight of documents such as PSURs, DSURs, and PBRERs, supporting regulatory compliance, team mentorship, and client delivery in global drug safety reporting. Join a mission-driven organization that advances drug safety globally.


Key Responsibilities:

  • Review RMPs, PSURs, PBRERs, DSURs, PADERs, and Canadian aggregate reports for medical accuracy and cohesiveness

  • Oversee project performance and ensure timely delivery within quality and compliance standards

  • Mentor and train junior team members to ensure independent and efficient report generation

  • Manage end-to-end logistics of safety report development in collaboration with cross-functional teams

  • Prepare project-specific presentation slides for internal and external stakeholders

  • Participate in audits/inspections by clients and regulatory authorities

  • Maintain and update all trackers and training documentation

  • Contribute to drafting and implementation of SOPs and work instructions

  • Provide guidance on client-specific documentation and regulatory expectations

  • Support ICSRs and literature review teams as needed

  • Conduct daily status meetings, report allocation, and performance tracking


Required Skills & Qualifications:

  • 1–3+ years of experience in pharmacovigilance, particularly aggregate reporting

  • Strong understanding of medical terminology and pharmacovigilance guidelines (GVP, ICH-GCP, USFDA)

  • Proficiency in authoring and reviewing RMPs, DSURs, PBRERs, PSURs, and PADERs

  • Competence with Microsoft Office Suite (Word, Excel, PowerPoint)

  • Excellent written and verbal communication skills in English

  • Strong organizational skills, attention to detail, and teamwork orientation

  • Familiarity with regulatory expectations and patient safety obligations


Perks & Benefits:

  • Work with global clients and regulatory bodies

  • Continuous training and skill enhancement programs

  • Opportunity to lead and mentor teams

  • Exposure to cross-functional pharmacovigilance operations

  • Inclusive and growth-oriented company culture


Company Description:

Navitas Life Sciences is a global clinical research organization focused on delivering end-to-end solutions in clinical trials, pharmacovigilance, and regulatory services. With a strong legacy in advancing public health, we help clients navigate complex regulatory landscapes and bring safe, effective therapies to market.


Work Mode: On-site or Hybrid (Based on location and project needs)


Call to Action:

If you're a detail-oriented medical reviewer with pharmacovigilance expertise, apply today to lead safety writing operations at Navitas Life Sciences. Shape the future of global drug safety.

Apply Now at ThePharmaDaily.com