Global CRO Parexel has announced an exciting opportunity for Medical Writer I – Patient Safety in Bengaluru. This full-time pharmacovigilance and safety medical writing role is ideal for life sciences professionals looking to build a strong career in aggregate safety reporting, signal management, and risk management planning.
If you have expertise in PSUR, PBRER, DSUR, signal detection, and safety analysis, this Medical Writer I role at Parexel could be your next career move in the clinical research and drug safety domain.
Application Deadline: 18 February 2026
Location: Bengaluru, India
Job Type: Full-time
About Parexel
Parexel is a globally recognized Contract Research Organization (CRO) providing clinical development, regulatory consulting, pharmacovigilance, and market access solutions. The company partners with pharmaceutical, biotech, and medical device organizations to improve global health outcomes.
Key Responsibilities – Medical Writer I (Patient Safety)
1️⃣ Aggregate Safety Reports & Documentation
- Preparation and compilation of PSURs, PBRERs, DSURs, PADERs, SASRs, ARBE reports
- Drafting Addendum to Clinical Overviews (ACO)
- Supporting medium-complexity safety reports under supervision
- Ensuring data integrity and quality review of safety documents
- Coordinating submissions to regulatory authorities
- Preparing labeling comparison documents and appendices
2️⃣ Safety Analysis & Signal Management
- Performing signal detection activities
- Quantitative and qualitative safety data analysis
- Managing signal tracking logs
- Supporting simple molecule safety evaluation
- Preparing Drug Safety Reports (DSR) & Signal Evaluation Reports (SER)
- Conducting literature searches for safety assessment
- Resolving discrepancies in line listings
3️⃣ Risk Management Plan (RMP)
- Assisting in preparation and updates of RMP documents
- Ensuring compliance with global pharmacovigilance regulations
- Supporting risk documentation consistency
4️⃣ General Scientific & Client Support
- Strong knowledge of medical terminology
- Working knowledge of MedDRA & WHO-DD
- Maintaining audit-ready documentation
- Collaborating with global cross-functional teams
- Managing client communication effectively
Required Qualifications
- University degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Microbiology
- Biotechnology
- Biochemistry
- Biomedical Sciences
- Dentistry / Physiotherapy (advantage)
- Understanding of global pharmacovigilance regulations
- Familiarity with:
- PSUR, PBRER, DSUR preparation
- Signal management processes
- MedDRA & WHO-DD coding
- Pharmacovigilance databases
- Prior pharmacovigilance or safety writing experience preferred
Required Skills
- Scientific writing & regulatory documentation expertise
- Strong analytical thinking for safety data interpretation
- Knowledge of aggregate safety reporting
- Excellent time management & deadline adherence
- Proficiency in MS Office & safety systems
- Adaptability to evolving PV regulations
Salary & Benefits (Estimated)
- Expected Salary Range: ₹6,50,000 – ₹9,50,000 per annum (based on experience)
- Global CRO exposure
- Regulatory and pharmacovigilance career growth
- International client interaction
- Advanced safety writing experience
Why This Medical Writer I Role is Important
This role plays a critical function in global drug safety and pharmacovigilance compliance. By contributing to PSUR, DSUR, and signal management activities, professionals ensure patient safety and regulatory compliance across global markets.
For candidates interested in transitioning from pharmacovigilance operations to safety medical writing, this is an excellent entry-to-mid-level opportunity.
How to Apply
