Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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