Parexel is hiring for the position of Medical Writer I – Patient Safety across Hyderabad, Bengaluru and Bengaluru-Remote locations in India. This opportunity is suitable for candidates with educational backgrounds in Pharmacy, Life Sciences, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy, Biomedical Sciences and related healthcare disciplines.
The Parexel Medical Writer I Patient Safety role focuses on pharmacovigilance, aggregate safety reporting, signal management, risk management plans and scientific safety documentation. Candidates with prior pharmacovigilance or related experience are preferred.
Professionals looking to develop their careers in pharmacovigilance medical writing, drug safety, aggregate reporting and signal management can review the eligibility criteria and apply before the closing date.
Key Responsibilities
Selected candidates for the Parexel Medical Writer I – Patient Safety position may be responsible for:
- Preparing and compiling scheduled and ad-hoc aggregate safety reports.
- Contributing to PSURs, PBRERs, DSURs, PADERs, ACOs, SASRs, ARBE reports and other safety documentation.
- Independently leading simpler safety reports and supporting medium-complexity reports under guidance.
- Incorporating reviewer feedback and performing quality checks to maintain consistency and data integrity.
- Coordinating safety document submissions to regulatory authorities across different regions.
- Preparing supporting documentation, including local-versus-global labeling comparisons, INN checks and appendices.
- Performing signal detection using safety databases, clinical information, scientific literature and regulatory sources.
- Conducting quantitative and qualitative safety-data analyses to identify potential signals.
- Maintaining signal trackers and supporting signal-management activities.
- Assisting with Drug Safety Reports (DSRs), Signal Evaluation Reports (SERs) and related assessments.
- Conducting literature searches and summarizing relevant safety information.
- Reviewing and resolving discrepancies in safety-data sources and line listings.
- Assisting with the preparation and updating of Risk Management Plans (RMPs).
- Maintaining audit-ready safety documentation and supporting inspection-readiness activities.
- Communicating with global teams and clients regarding timelines, document cycles and routine queries.
- Supporting quality-control activities and compliance with applicable global pharmacovigilance requirements.
Qualification
Preferred: University degree in Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy, Life Sciences, Health Sciences, Biomedical Sciences or a related discipline, or an equivalent combination of relevant training and work experience.
Clinical exposure in hospital-based environments is considered advantageous.
Experience Required
Prior experience in pharmacovigilance or a related field is preferred.
The official job description does not specify a mandatory minimum number of years of experience. Candidates should therefore assess their suitability based on their pharmacovigilance knowledge, scientific writing skills and relevant practical exposure rather than assuming a fixed experience threshold.
Skills Required
Candidates should ideally demonstrate:
- Knowledge of pharmacovigilance and drug-safety concepts
- Understanding of global pharmacovigilance regulations
- Scientific and medical writing skills
- Analytical and problem-solving abilities
- Knowledge of medical terminology
- Familiarity with MedDRA and WHO Drug Dictionary (WHO-DD)
- Understanding of aggregate safety reporting
- Knowledge of signal detection and signal management
- Strong written and verbal communication
- Ability to work with global and cross-functional teams
- Organizational and time-management skills
- Proficiency with MS Office and relevant medical-writing tools
- Familiarity with pharmacovigilance databases
- Ability to maintain accurate and audit-ready documentation
This Medical Writer I Patient Safety job at Parexel provides exposure to several important pharmacovigilance activities, including:
Aggregate Safety Reporting: PSUR, PBRER, DSUR, PADER, SASR, ACO and ARBE-related documentation.
Signal Management: Signal detection, quantitative and qualitative safety analysis, signal tracking, literature review, DSRs and SERs.
Risk Management: Preparation and maintenance of Risk Management Plans and related safety documentation.
Regulatory Compliance: Supporting submissions, quality control, inspection readiness and compliance with global pharmacovigilance requirements.
Why Consider This Opportunity?
The role provides an opportunity to work across multiple areas of patient safety rather than focusing exclusively on a single pharmacovigilance activity. Professionals can gain exposure to aggregate safety reports, signal management, risk management, literature surveillance, safety analysis and global regulatory requirements.
The position also involves collaboration with global stakeholders and provides exposure to client communication, regulatory submissions and quality-management processes.
Salary
Parexel has not disclosed the salary for this vacancy in the supplied job posting.
For structured-data purposes, an estimated market range of approximately ₹5,00,000–₹9,00,000 per year may be considered for comparable roles in India. This is an editorial estimate only and not an officially disclosed Parexel salary range. Actual compensation can vary based on experience, skills, location and internal compensation policies.
How to Apply
