Job Overview
| Particulars | Details |
|---|---|
| Position | Medical Writer I – Patient SafetyCompany Name: Parexel |
| Company | Parexel |
| Location | Hyderabad, Bengaluru & Bengaluru-, India |
| Job Type | |
| Category / Department | IT |
| Application Mode | Online |
🏢 About Parexel
Parexel is a global biopharmaceutical services organization supporting pharmaceutical and life sciences companies across clinical development, regulatory and commercialization-related activities.
This Medical Writer I – Patient Safety opportunity is aligned with the company's patient-safety and pharmacovigilance activities.
The position offers exposure to multiple areas of safety medical writing, including:
Aggregate safety reporting
Signal detection and signal management
Risk Management Plans
Safety literature review
Regulatory safety documentation
Safety-data analysis
Global pharmacovigilance requirements
Quality control
Regulatory submissions
Inspection readiness
The role can be particularly relevant for candidates who want to build a career in Pharmacovigilance Medical Writing, Drug Safety, Aggregate Reporting and Patient Safety.
Parexel – India
The supplied vacancy mentions work locations in:
Hyderabad, India
Bengaluru, India
Bengaluru-Remote, India
A specific office street address was not provided in the supplied job information.
💡 Editor's Note / Preparation Tip
Resume Tips
Candidates applying for this role should make their resumes clearly reflect relevant pharmacovigilance, medical writing and scientific research experience.
Consider highlighting:
Pharmacovigilance experience
Medical writing projects
Scientific literature review
Drug-safety knowledge
Aggregate safety reporting
PSUR/PBRER/DSUR exposure
Signal detection or signal management
Risk Management Plan experience
MedDRA knowledge
WHO-DD familiarity
Safety database exposure
Regulatory documentation
Clinical research experience
Healthcare or hospital exposure
For Freshers / Early-Career Candidates
If you do not have direct pharmacovigilance experience, emphasize relevant academic projects, internships, research work, scientific writing, literature-review experience and knowledge of drug-safety concepts.
Interview Preparation
Candidates should revise:
Pharmacovigilance fundamentals
Adverse events and adverse drug reactions
Seriousness and expectedness concepts
Aggregate safety reports
PSUR and PBRER
DSUR
PADER
Signal detection
Signal management
Risk Management Plans
MedDRA
WHO-DD
Literature surveillance
Safety-data analysis
Global PV regulations
Medical writing principles
Quality control and document review
Candidates should also be prepared to explain how they would review scientific literature, interpret safety information and maintain accuracy in regulatory documents.
📝 Job Description
🚨 HIRING ALERT | MEDICAL WRITER I – PATIENT SAFETY | PAREXEL
Are you interested in building your career in Pharmacovigilance, Patient Safety and Medical Writing?
Parexel is hiring for the position of Medical Writer I – Patient Safety in Hyderabad, Bengaluru and Bengaluru-Remote, India.
This opportunity is particularly relevant for professionals from Pharmacy, Life Sciences, Biomedical Sciences and related healthcare/scientific disciplines.
💼 POSITION
Medical Writer I – Patient Safety
🏢 COMPANY
Parexel
📍 LOCATIONS
Hyderabad | Bengaluru | Bengaluru-Remote, India
🎓 ELIGIBILITY
Relevant university degree in:
✔ Pharmacy
✔ Microbiology
✔ Biochemistry
✔ Biotechnology
✔ Biophysics
✔ Dentistry
✔ Physiotherapy
✔ Life Sciences
✔ Health Sciences
✔ Biomedical Sciences
✔ Related disciplines
Equivalent combinations of relevant training and work experience may also be considered.
💼 EXPERIENCE
Not specifically stated
Previous experience in pharmacovigilance or a related field is preferred.
The supplied vacancy does not mention a fixed minimum number of years of experience.
🔬 WHAT YOU MAY WORK ON
The role provides exposure to a broad range of patient-safety and pharmacovigilance activities, including:
✔ Aggregate Safety Reporting
✔ PSURs
✔ PBRERs
✔ DSURs
✔ PADERs
✔ SASRs
✔ ACOs
✔ ARBE reports
✔ Signal Detection
✔ Signal Management
✔ Drug Safety Reports
✔ Signal Evaluation Reports
✔ Risk Management Plans
✔ Literature Surveillance
✔ Safety-data Analysis
✔ Regulatory Safety Documentation
✔ Quality Control
✔ Inspection Readiness
🌎 GLOBAL EXPOSURE
This position can provide experience working with global pharmacovigilance requirements, regulatory safety documentation, international submissions and cross-functional stakeholders.
⭐ WHY CONSIDER THIS ROLE?
Professionals joining this function can gain exposure across several important areas rather than working on only one pharmacovigilance activity.
The role can help develop expertise in:
🔹 Patient Safety
🔹 Pharmacovigilance Medical Writing
🔹 Aggregate Reporting
🔹 Signal Management
🔹 Risk Management
🔹 Literature Surveillance
🔹 Regulatory Safety
🔹 Quality & Compliance
💰 SALARY
Salary is not disclosed in the supplied Parexel vacancy.
For editorial/market-reference purposes only, a comparable India market range of approximately ₹5,00,000–₹9,00,000 per year may be considered.
⚠️ Important: This is an editorial estimate and NOT an officially disclosed Parexel salary range. Actual compensation may vary depending on experience, skills, location and the company's internal compensation structure.
🎯 Key Responsibilities
- ✓ The Medical Writer I – Patient Safety may be involved in the following activities:
- ✓ Preparing scheduled and ad-hoc aggregate safety reports
- ✓ Supporting the preparation of PSURs, PBRERs, DSURs, PADERs, ACOs, SASRs and ARBE reports
- ✓ Taking ownership of simpler safety reports and assisting with medium-complexity reports under appropriate guidance
- ✓ Reviewing documents and incorporating feedback from stakeholders
- ✓ Performing quality checks to maintain consistency, completeness and data integrity
- ✓ Supporting safety-document submissions to regulatory authorities across different regions
- ✓ Preparing supporting safety documentation and appendices
- ✓ Conducting local-versus-global labeling comparisons
- ✓ Performing INN checks and related documentation activities
- ✓ Conducting signal detection using safety databases, clinical information, scientific literature and regulatory sources
- ✓ Performing quantitative and qualitative safety-data assessments
- ✓ Identifying and evaluating potential safety signals
- ✓ Maintaining signal trackers and supporting signal-management activities
- ✓ Assisting with Drug Safety Reports (DSRs)
- ✓ Supporting preparation of Signal Evaluation Reports (SERs)
- ✓ Conducting literature searches and summarizing relevant safety information
- ✓ Reviewing safety-data sources and line listings
- ✓ Investigating and resolving discrepancies in safety information
- ✓ Supporting preparation and maintenance of Risk Management Plans (RMPs)
- ✓ Maintaining audit-ready safety documentation
- ✓ Supporting inspection-readiness activities
- ✓ Communicating with global teams and clients regarding document timelines, review cycles and routine queries
- ✓ Supporting quality-control activities
- ✓ Following applicable global pharmacovigilance requirements and procedures
💡 Required Qualifications & Skills
🚀 Career Guidance & Interview Insights
To help you succeed, we've compiled original preparation guides, resume keywords, and growth analytics for this category of role.
Joining as a Medical Writer I – Patient SafetyCompany Name: Parexel offers a fantastic opportunity to work at the forefront of technological innovation. You will be exposed to modern software development lifecycles, collaborate with cross-functional product teams, and design scalable architectures that directly impact end-users. The continuous learning curve in tech ensures that your programming, debugging, and system engineering skills remain highly marketable and sharp.
The career roadmap in technology is highly rewarding. Typical progression starts as a Junior Software Engineer, moving to Associate Developer and then Senior Software Engineer (3-6 years). From there, professionals choose between an individual contributor track—becoming a Tech Lead, Staff Engineer, and Principal Architect—or a management track, advancing to Engineering Manager, Director of Engineering, and Chief Technology Officer (CTO).
Expected Technical & Behavioral Questions:
- Q1: How do you optimize database query performance?
Answer Tip: Talk about indexing strategies, query execution plan analysis, avoiding N+1 queries, and implementing caching layers (like Redis). - Q2: Explain the differences between Microservices and Monolithic architecture.
Answer Tip: Highlight scaling advantages, loose coupling, independent deployments, network latency considerations, and data consistency challenges in microservices. - Q3: How do you handle merge conflicts in Git?
Answer Tip: Explain checking out the local branch, pulling the latest main branch, running git merge, opening the conflicted files to resolve blocks manually, and committing the resolved merge.
To pass automated ATS (Applicant Tracking System) screening and catch the recruiter's eye, tailor your resume with the following tips:
- Keywords to include: Software Engineering, SDLC, OOP, CI/CD Pipelines, SQL databases, Agile, Unit Testing, Code Review, Cloud Architectures (AWS/Azure).
- Format: Use a clean, single-column resume format. Avoid graphics, text boxes, or tables which can scramble ATS parser outputs.
- Quantify Results: Instead of writing 'wrote code', write 'Developed a caching system that reduced server response times by 35%.'
Estimated compensation for this role type in India is ₹3,50,000 - ₹6,00,000 per annum (Freshers/Entry level). The actual salary package offered depends on factors such as company size, work mode (remote or on-site), individual technical proficiency, and negotiations during final HR rounds.
Highly recommended certifications include: AWS Certified Solutions Architect, Microsoft Certified: Azure Fundamentals, Certified Kubernetes Administrator (CKA), Oracle Certified Professional Java SE, or tech-stack specific achievements (e.g. Meta Front-End Developer certification).
Frequently Asked Questions
1. What position is Parexel hiring for?
Parexel is hiring for the position of Medical Writer I – Patient Safety.
2. Where is this position available?
The vacancy lists Hyderabad, Bengaluru and Bengaluru-Remote, India as locations.
3. What educational qualifications are accepted?
Relevant degrees in Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy, Life Sciences, Health Sciences, Biomedical Sciences or related disciplines are preferred.
4. Is previous pharmacovigilance experience mandatory?
The supplied job information states that previous pharmacovigilance or related experience is preferred. It does not specify a mandatory minimum number of years.
5. Can Life Sciences graduates apply?
Yes. Life Sciences and related healthcare/scientific disciplines are included among the preferred educational backgrounds.
6. What type of medical writing is involved?
The role focuses primarily on patient-safety and pharmacovigilance medical writing, including aggregate safety reports, signal-management documents, risk-management documentation and related regulatory safety materials.
7. What aggregate reports may be handled?
The role may involve PSURs, PBRERs, DSURs, PADERs, ACOs, SASRs and ARBE reports, along with other safety documentation.
8. What is signal management?
Signal management involves identifying, assessing, tracking and evaluating potential safety signals using available safety data, literature, clinical information and regulatory sources.
9. Is knowledge of MedDRA useful for this role?
Yes. Familiarity with MedDRA and WHO Drug Dictionary (WHO-DD) is listed among the desirable skills.
10. What career area does this role support?
The position can provide professional exposure to pharmacovigilance, patient safety, medical writing, aggregate reporting, signal management, risk management and global regulatory safety activities.
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