Looking to build a career in medical writing, pharmacovigilance, and regulatory safety reporting? Parexel is hiring Medical Writer I / Medical Writer II professionals for a remote role in India (Hyderabad-based team).
This opportunity is ideal for candidates with experience in aggregate safety reports, signal detection, clinical narratives, and regulatory documentation. At Parexel, you will contribute directly to drug safety, risk management, and global regulatory submissions, impacting patient health worldwide.
If you have expertise in PSUR, PBRER, RMP writing, and pharmacovigilance documentation, this role offers strong career growth in the CRO domain.
Job Overview
- Role: Medical Writer I / Medical Writer II
- Company: Parexel
- Location: India (Remote โ Hyderabad team)
- Job Type: Full-Time
- Application Deadline: April 10, 2026
- Experience: Freshers to experienced (PV/Regulatory preferred)
Key Responsibilities
1. Aggregate Safety Reports & Regulatory Writing
- Prepare and update RMPs, CC-RMPs, PSUR, PBRER, DSUR, PADER, ACOs, INDARs
- Draft Clinical Overviews, Safety Evaluation Reports, Drug Safety Reports
- Handle health authority response documents and labeling comparisons
- Ensure compliance with global pharmacovigilance regulations and SOPs
2. Literature Review & Epidemiology
- Conduct systematic literature review and critical appraisal
- Develop literature search strategies for epidemiology sections
- Analyze incidence, prevalence, and risk factors for safety reports
- Apply epidemiological calculations for safety signal validation
3. Clinical Narrative Writing (CSR Support)
- Prepare patient narratives using clinical & safety databases
- Collaborate with Study Management Teams (SMT)
- Perform quality checks, formatting, and final compilation
4. Signal Detection & Risk Management
- Perform signal detection and evaluation (qualitative + quantitative)
- Manage end-to-end signal lifecycle (tracking, analysis, reporting)
- Present findings in cross-functional safety review meetings
5. Quality, Compliance & Client Interaction
- Ensure data consistency, integrity, and compliance
- Conduct QC checks across aggregate reports
- Act as client-facing medical writer (for senior roles)
- Participate in audits, inspections, and process improvements
Required Qualifications
Education
- B.Pharm / M.Pharm / MSc (Life Sciences, Biotech, Microbiology, Biochemistry)
- MBBS / BDS / Nursing / Physiotherapy (preferred advantage)
Experience
- Experience in Pharmacovigilance, Regulatory Affairs, or Medical Writing
- Knowledge of aggregate reports (PSUR, PBRER, DSUR, RMP)
Skills
- Strong medical writing and scientific documentation skills
- Knowledge of drug safety regulations and PV systems
- Expertise in data interpretation and literature review
- Excellent communication, analytical, and organizational skills
- Proficiency in MS Office and web-based tools
Preferred Keywords
Medical Writer jobs India, Pharmacovigilance writing jobs, PSUR PBRER jobs, RMP writing careers, clinical safety writing jobs, aggregate report writing roles, remote medical writing India
Salary & Benefits (Estimated)
- Salary Range: โน6 LPA โ โน18 LPA (based on experience & level)
- Remote work flexibility
- Exposure to global regulatory projects
- Career growth in CRO & drug safety domain
- Opportunity to work with international clients & regulatory agencies
Why Join Parexel?
- Leading global CRO (Clinical Research Organization)
- Strong focus on patient-centric innovation
- Work across clinical trials, regulatory, and safety domains
- High exposure to global pharmacovigilance practices
How to Apply
