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
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