India's DMPLOI - Jobs & Networking App
Parexel
Company: Parexel
Job Title: Medical Writer I / Medical Writer II – Patient Safety
Location: Hyderabad, Telangana, India
Work Mode: Hybrid / On-site / Remote (as per role requirements)
Department: Pharmacovigilance / Medical Writing / Patient Safety
Job Type: Full-Time
Experience Required: 2+ years for Medical Writer I; 4+ years for Medical Writer II
Qualification: Degree in Life Sciences, Pharmacy, Healthcare, Biomedical Sciences, or a related field
About Parexel
Parexel is a leading global clinical development and consulting organization that partners with biopharmaceutical companies and research sites to advance clinical research and improve patient outcomes. With a global workforce of over 22,000 employees, Parexel supports the development of new therapies through scientific expertise, innovation, and patient-focused clinical trials.
The company is expanding its team and inviting qualified professionals to apply for Medical Writer I / Medical Writer II positions in Patient Safety.
Job Description
Parexel is seeking skilled Medical Writers to support pharmacovigilance activities, regulatory safety documentation, and signal management. The selected candidates will contribute to the preparation of safety reports, evaluation of emerging safety signals, and maintenance of regulatory compliance across different regions.
This opportunity is suitable for professionals with experience in pharmacovigilance, medical writing, and safety assessment who are interested in contributing to global clinical development and patient safety.
Key Responsibilities
- Prepare and develop aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
- Conduct signal detection activities by reviewing safety databases, clinical data, scientific literature, and regulatory sources.
- Prepare Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs) with evidence-based conclusions.
- Perform systematic literature searches and reviews to identify emerging safety trends.
- Maintain signal tracking logs, investigate data discrepancies, and ensure data integrity.
- Assist in preparing and updating Risk Management Plans (RMPs).
- Coordinate with clients and cross-functional teams to address queries and provide project updates.
- Maintain audit-ready documentation and support regulatory inspection readiness.
- For Medical Writer II, mentor junior team members, lead complex client discussions, and contribute to process improvements.
Required Qualifications and Skills
- A university degree in Pharmacy, Life Sciences, Microbiology, Biochemistry, Biotechnology, Biomedical Sciences, or a related discipline.
- Medical Writer I: At least 2 years of relevant experience.
- Medical Writer II: At least 4 years of relevant experience.
- Understanding of global pharmacovigilance regulations, medical terminology, and safety assessment concepts.
- Proficiency in medical writing tools and Microsoft Office applications.
- Familiarity with pharmacovigilance databases and coding dictionaries such as MedDRA and WHO-DD.
- Strong scientific writing, analytical thinking, communication, and problem-solving skills.
- Ability to manage multiple projects while maintaining accuracy and regulatory compliance.
Preferred Qualifications
- Previous experience in pharmacovigilance or safety assessment.
- Clinical research experience or exposure to hospital-based environments.
- Expertise in specific therapeutic areas or product types.
- Familiarity with regulatory submission processes across multiple regions.
Why Join Parexel?
- Opportunity to work with a global clinical research organization.
- Exposure to regulatory medical writing and patient safety activities.
- Opportunities for professional development and career growth.
- Collaboration with cross-functional teams in a quality-focused environment.
How to Apply
Interested and eligible candidates should visit the official Parexel careers website to search for the Medical Writer I / Medical Writer II – Patient Safety opening in Hyderabad, India, and submit their application through the official recruitment portal.
Official Careers Website: https://jobs.parexel.com/
To apply for this job please visit jobs.parexel.com.
