Pharmacovigilance Drug Safety Medical Writing Jobs in Hyderabad at MSN Group and drug safety medical writing professionals with global regulatory experience.
Hiring Organization: MSN Group
Job Title: Medical Reviewer – Pharmacovigilance & Drug Safety Medical Writing
Job Location: Hyderabad, Telangana, India
Employment Type: Full-Time, Permanent
Experience Required: 2–4 Years
Education Required: MBBS, MD, MDS, Pharm.D, M.Pharm
Department: Research & Development (Pharmacovigilance)
Industry: Pharmaceutical & Life Sciences
Openings: 1
Job Type: Verified Job | Online Application
Job Description
MSN Group is hiring a Medical Reviewer – Pharmacovigilance & Drug Safety Medical Writing for its Hyderabad location. This role is suited for qualified medical and pharmacy professionals with hands-on experience in pharmacovigilance medical review, aggregate safety reporting, and global drug safety documentation. Pharmacovigilance Drug Safety Medical Writing Jobs
The position plays a critical role in ensuring clinical accuracy, regulatory compliance, and lifecycle safety management of pharmaceutical products across regulated markets. Pharmacovigilance Drug Safety Medical Writing Jobs
Key Responsibilities
Medical Review & Case Processing
- Perform medical review of Individual Case Safety Reports (ICSRs) from spontaneous sources, literature, and regulatory authorities
- Assess adverse events for seriousness, expectedness, and clinical relevance
- Review and validate causality assessments
- Conduct MedDRA coding review for adverse events, medical history, and concomitant medications
- Evaluate product role classification (suspect, concomitant, interacting)
- Review case narratives for medical accuracy, clinical consistency, and regulatory completeness
- Perform label assessment against reference safety information
Aggregate Reporting & Safety Documentation
- Draft, review, and medically validate aggregate safety reports including:
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs)
- Review and support Risk Management Plans (RMPs)
- Contribute to signal management reports and documentation
- Support pharmacovigilance medical writing for regulatory submissions
Pharmacovigilance Drug Safety Medical Writing Jobs
Eligibility & Qualifications
Educational Background
Medical Track:
- MBBS / MD (Pharmacology preferred) / MDS
Pharmacy Track:
- Pharm.D or M.Pharm with 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 activities
- Experience working with global regulatory safety documentation
Core Skills Required
- Strong knowledge of global pharmacovigilance regulations
- Expertise in ICSR medical review and aggregate safety reports
- Accurate application of MedDRA terminology
- High attention to clinical detail and documentation quality
- Excellent written and verbal communication in English
- Proficiency in MS Office for safety documentation
- Strong organizational and time-management skills
Pharmacovigilance Drug Safety Medical Writing Jobs
Why Join MSN Group?
- Direct involvement in global pharmacovigilance and regulatory safety activities
- Exposure to end-to-end drug safety documentation across product lifecycle
- Work within a structured, compliance-driven safety environment
- Collaboration with cross-functional PV, regulatory, and clinical teams
- Strong foundation for long-term careers in drug safety and regulatory strategy
Pharmacovigilance Drug Safety Medical Writing Jobs
Career Growth Opportunities
This role can lead to advanced positions such as:
- Senior Medical Reviewer
- Lead – Drug Safety & Medical Writing
- Signal Management Specialist
- Risk Management / Benefit–Risk Assessment Lead
- Pharmacovigilance Medical Advisor
Pharmacovigilance Drug Safety Medical Writing Jobs
How to Apply
Apply online through the official Application Link provided by MSN Group.
Ensure your CV highlights pharmacovigilance experience, aggregate report exposure, and medical writing expertise.
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