The Medical Reviewer role at MSN Group is designed for qualified medical and pharmacy professionals with hands-on experience in pharmacovigilance and drug safety medical writing.
This full-time, permanent position is based in Hyderabad, a major hub for pharmaceutical R&D and safety operations.
The role is critical to ensuring the scientific accuracy, regulatory compliance, and clinical integrity of global drug safety documentation across a product’s lifecycle.
About the Company
MSN Group is a vertically integrated pharmaceutical company with a strong presence across APIs, formulations, and drug delivery systems. The organization supports regulated markets and maintains structured pharmacovigilance systems aligned with global regulatory expectations. Its R&D-driven approach emphasizes compliance, documentation quality, and lifecycle safety management for marketed and investigational products.
Job Overview
Role: Medical Reviewer
Company: MSN Group
Location: Hyderabad
Experience Required: 2–4 years
Employment Type: Full-time, Permanent
Industry: Pharmaceutical & Life Sciences
Department: Research & Development
Openings: 1
This role sits at the intersection of pharmacovigilance operations and medical writing, with responsibility for medical review, signal evaluation, and aggregate safety documentation.
Key Responsibilities
Core Responsibilities
- Perform medical review of individual case safety reports (ICSRs) sourced from company data, literature, and regulatory authorities.
- Ensure appropriate selection and medical assessment of adverse events, including seriousness criteria and expectedness.
- Conduct MedDRA coding review for adverse events, medical history, and concomitant conditions.
- Review and validate causality assessments performed by reporters or internal teams.
- Perform label assessment to evaluate listedness of adverse events against reference safety information.
- Determine and review product role classification (suspect, concomitant, interacting).
- Evaluate case narratives for medical accuracy, clinical coherence, and regulatory completeness.
Aggregate Reporting & Risk Management
- Draft, review, and medically validate aggregate safety reports, including:
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Conduct medical review of Risk Management Plans (RMPs), ensuring alignment with regulatory guidance.
- Review Signal Management Reports, supporting signal validation and documentation.
- Support pharmacovigilance operations related to medical writing and regulatory submissions.
Eligibility & Required Skills
Educational Qualifications
- Primary Medical Track:
- MBBS or MD (preferably Pharmacology)
OR
- Pharmacy Track:
- PharmD or M.Pharmacy with prior experience in drug safety medical writing
Experience Requirements
- 2–4 years of experience in pharmacovigilance medical review or drug safety medical writing
- Hands-on exposure to PSURs, PADERs, DSURs, RMPs, and signal management reports
- Experience working with global regulatory safety documentation
Core Skills (Role-Specific Only)
- Strong understanding of pharmacovigilance regulations and safety reporting standards
- Proficiency in medical review of ICSRs and aggregate reports
- Accurate application of MedDRA terminology
- High attention to clinical detail and document quality
- Effective written and verbal communication in English
- Strong organizational and time-management skills
- Advanced working knowledge of MS Office for safety documentation
Why This Role Matters
Medical Reviewers play a central role in safeguarding patient safety by ensuring that safety data is clinically sound, accurately interpreted, and correctly presented to regulators. At MSN Group, this role directly supports regulatory compliance, signal detection, and lifecycle risk management for pharmaceutical products. Decisions made during medical review influence regulatory outcomes, product labeling, and ongoing benefit-risk evaluations, making this position essential to both public health protection and sustainable product commercialization.
Benefits & Professional Exposure
- Direct involvement in global pharmacovigilance and regulatory safety activities
- Exposure to end-to-end safety documentation, from case review to aggregate reporting
- Collaboration with cross-functional PV, regulatory, and clinical teams
- Experience aligned with international regulatory standards
- Structured environment focused on documentation quality and compliance
Career Path After This Role
Professionals in this role can progress into advanced positions such as:
- Senior Medical Reviewer
- Lead – Drug Safety & Medical Writing
- Signal Management Specialist
- Risk Management or Benefit–Risk Assessment Lead
- Pharmacovigilance Medical Advisor
The role also provides a strong foundation for leadership tracks within pharmacovigilance, regulatory affairs, and safety strategy functions.
How to Apply
