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Navitas Life Sciences, a leader in providing comprehensive services across the clinical, regulatory, and safety domains, is seeking an experienced and detail-oriented Senior/Lead Medical Reviewer. This is a fantastic opportunity to join our growing Pharmacovigilance and Safety team in Bangalore.
We are looking for a professional with a strong background in aggregate reporting and signal management to take on a key role in our safety writing operations. You will mentor a dedicated team and ensure the highest standards of quality and compliance.
Role Overview
As a Senior/Lead Medical Reviewer, you will be responsible for the implementation and oversight of operational tasks within our safety writing team. You will play a crucial part in mentoring team members and ensuring all safety reports meet client expectations and global regulatory requirements.
Key Responsibilities
Project & Team Leadership
- Oversee service performance and ensure the timely development of safety reports.
- Mentor employees, enabling them to work independently and meet project timelines, budget, and quality standards.
- Act as the primary point of contact for our aggregate team and clients.
- Assist the Manager in report allocation, tracking, and scheduling.
- Conduct daily status meetings and provide training to enhance team performance.
Medical & Safety Writing
- Review Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate documents for medical cohesiveness and accuracy.
- Author and review RMPs, DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required.
- Provide subject matter expertise for the finalization of all aggregate reports and their annexes, resolving issues as they arise.
Compliance & Quality Assurance
- Ensure project compliance in delivering high-quality reports.
- Participate in internal and external audits and inspections conducted by clients and health authorities.
- Ensure all project-related trackers are maintained and updated in line with company and client-specific procedures.
- Support the drafting and implementation of SOPs and Work Instructions.
Cross-functional Support
- Assist the Individual Case Safety Report (ICSR) and Literature Review teams as needed based on workload.
- Develop and dispatch project-specific presentation slides for both internal and external stakeholders.
Desirable Skills and Experience
We are looking for a candidate who possesses a strong foundation in pharmacovigilance principles and excellent technical skills.
- Experience: 1 to 3+ years of hands-on experience in Aggregate Reporting, Signal Management, or RMP.
- Regulatory Knowledge:Â Deep knowledge of GCP, GVP, ICH, USFDA guidelines, and other global pharmacovigilance regulations.
- Medical Terminology:Â A good understanding of medical and pharmacovigilance terminology is essential.
- Software Proficiency:Â Strong command of MS Office suite (Word, Excel, PowerPoint).
- Soft Skills:Â Excellent motivation, strong English communication skills (written and spoken), structured work approach, and proven reliability and teamwork capabilities.
Qualifications
- Education:Â A Graduate or Post-Graduate degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, or a related field.
Job Details
- Job Title:Â Senior/Lead Medical Reviewer
- Department:Â Pharmacovigilance and Safety
- Level:Â Associate
- Employment Type:Â Full-Time
How to Apply
If you are a motivated professional looking to advance your career in pharmacovigilance with a leading organization, we would love to hear from you.
Please apply through the Navitas Life Sciences career portal or send your application to the relevant HR contact.
Verified Pharmacovigilance Job Post
The post is released by the Navitas LifeScience LinkedIn page. Click here to visit the post
Job Summary
| Role: | Senior/Lead Medical Reviewer |
| Company: | Navitas Life Sciences |
| Posted: | August 14, 2025 |
| Location:Â | Bangalore, India |