Parexel is hiring Medical Writer I and Medical Writer II – Patient Safety for its India locations, including Hyderabad, Bengaluru, Mohali, and remote work options. The role focuses on pharmacovigilance, medical writing, aggregate safety reports, signal detection, and regulatory safety documentation.
Candidates with experience in pharmacovigilance, Risk Management Plans (RMPs), and global safety regulations can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Parexel |
| Job Title | Medical Writer I / Medical Writer II |
| Department | Patient Safety |
| Job Category | Medical Writing / Pharmacovigilance |
| Job Location | Hyderabad, Bengaluru, Mohali, Mumbai (remote options listed) |
| Work Mode | Hybrid, on-site, or remote |
| Experience | 2+ years for Medical Writer I; 4+ years for Medical Writer II |
| Qualification | University degree in Life Sciences, Health, or Biomedical Sciences, or equivalent training and work experience |
| Job Requisition ID | R0000046349 |
Positions Available
1. Medical Writer I – Patient Safety
Candidates with at least 2 years of experience in pharmacovigilance, medical writing, or a related field can be considered for this position.
2. Medical Writer II – Patient Safety
This position requires at least 4 years of experience. Additional responsibilities include mentoring junior team members, leading complex client discussions, managing document review cycles, and contributing to process improvements.
Key Responsibilities
Selected candidates will support pharmacovigilance and regulatory safety activities, including:
- Preparing and compiling Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and other regulatory safety documents.
- Conducting signal detection using safety databases, clinical data, scientific literature, and regulatory websites.
- Preparing Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs).
- Performing systematic literature searches and reviewing safety data to identify emerging trends.
- Maintaining signal logs, tracking activities, and resolving discrepancies in safety data.
- Preparing and updating Risk Management Plans (RMPs) in accordance with regulatory requirements.
- Coordinating with clients and cross-functional teams and providing project updates.
- Maintaining audit-ready documentation, archiving source materials, and supporting inspection readiness.
Medical Writer II candidates will also mentor junior colleagues, provide feedback, manage complex stakeholder discussions, and support process improvement initiatives.
Eligibility and Qualifications
Applicants should meet the following requirements:
- A university degree in Life Sciences, Health, or Biomedical Sciences, including Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy, or an equivalent combination of training and work experience.
- At least 2 years of relevant experience for Medical Writer I or 4 years for Medical Writer II.
- Experience in pharmacovigilance, medical writing, or a related field.
- Understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.
- Familiarity with regulatory safety documents and submission processes.
Required Skills
- Scientific and medical writing
- Pharmacovigilance and patient safety
- Risk Management Plan (RMP) authoring and lifecycle management
- Signal detection and signal evaluation
- PSUR, PBRER, and DSUR preparation
- Literature search and safety data analysis
- Regulatory compliance and documentation quality control
- Medical writing tools and MS Office applications
- Familiarity with pharmacovigilance databases and coding dictionaries, including MedDRA and WHO-DD
- Client communication, stakeholder coordination, and time management
RMP Writing Expertise
The recruitment announcement also highlights core Risk Management experience, including:
- European Risk Management Plans (EU-RMPs) and local RMPs or annexures
- RMP authoring, updating, review, and lifecycle management
- Additional Risk Minimization Measures (aRMMs)
- Risk management documentation and regulatory compliance
- Quality control of risk management deliverables
- Health authority commitments and regulatory communications
- Audit and inspection readiness support
- Mailbox management and operational coordination
The RMP-focused requirements specify 2–5+ years of core Risk Management experience, with hands-on experience in RMP authoring, maintenance, and related activities. Knowledge of GVP Module V and global risk management processes is also required.
