Medical Writer Patient Safety Job at Parexel Bengaluru
Are you passionate about drug safety and scientific writing? The Medical Writer I – Patient Safety role at Parexel in Bengaluru offers an exciting opportunity to work on global safety reports, signal detection, and risk management plans. This Medical Writer Job position is ideal for life sciences graduates seeking a career in pharmacovigilance and regulatory medical writing. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
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Job Title: Medical Writer I – Patient Safety
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Location: Bengaluru, India
About the Company
Parexel is a leading global clinical research organization (CRO) that supports the development and delivery of innovative therapies. With expertise in clinical trials, regulatory consulting, and pharmacovigilance, Parexel partners with biopharmaceuticals companies to improve patient outcomes worldwide.
Key Responsibilities
- Prepare and compile aggregate safety reports such as PSURs, PBRERs, DSURs, PADERs, SASRs, and ARBE reports.
- Perform signal detection and safety data analysis using clinical, literature, and regulatory sources.
- Maintain signal logs and support safety assessments, including DSRs and SERs.
- Assist in preparing and updating Risk Management Plans (RMPs).
- Coordinate safety document submissions to regulatory authorities across regions.
- Conduct literature reviews and resolve data discrepancies to ensure data integrity.
- Maintain audit-ready documentation and support inspection readiness.
- Collaborate with cross-functional teams and manage client communications.
Educational Requirements
- University degree in Pharmacy
- Equivalent training and work experience may be considered.
- Clinical exposure in hospital-based environments is advantageous.
Skills Required
- Scientific and regulatory medical writing
- Pharmacovigilance and safety data analysis
- Knowledge of MedDRA and WHO-DD coding dictionaries
- Analytical thinking and problem-solving
- Strong communication and cross-functional collaboration
- Time management and project prioritization
- Proficiency in MS Office and medical writing tools
Why This Job Role?
This Medical Writer Job role offers a strong foundation in pharmacovigilance and global drug safety, providing exposure to regulatory submissions, signal management, and risk assessment. It is ideal for life sciences graduates seeking a long-term career in medical writing, drug safety, and clinical research. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
