Medical Writer I – Aggregate Reports | Remote (India)
Job Summary:
Parexel is hiring an experienced Medical Writer I to manage global aggregate reports such as PSURs, PBRERs, DSURs, and RMPs for pharmaceutical safety submissions. This fully remote position in India is ideal for pharmacovigilance experts skilled in regulatory documentation, data review, signal detection, and literature evaluation. Join a team dedicated to delivering high-quality clinical and post-marketing safety documentation for worldwide health authority compliance.
Key Responsibilities:
Prepare, update, and merge Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs).
Develop responses to health authority queries with RMS updates.
Handle scheduled and unscheduled aggregate reports including PSURs, PBRERs, DSURs, PADERs, SASRs, ACOs, ARBE reports, and more.
Draft comparison documents for local vs. global labeling and verify INNs for PSRs.
Conduct systematic literature reviews for epidemiological data inclusion in reports.
Apply epidemiological calculations to published data to estimate background rates.
Generate and review Line Listings, ensuring data accuracy and discrepancy resolution.
Perform compliance activities for quality assurance across various aggregate reports.
Distribute final safety reports to global stakeholders and health authorities.
Schedule, attend, and document internal and client meetings, track action items.
Required Skills & Qualifications:
Bachelor’s/Master’s degree in Life Sciences, Pharmacy, or Medicine.
Proven experience in preparing aggregate safety reports (PSUR, PBRER, DSUR, RMP).
Familiarity with global pharmacovigilance regulations and guidelines.
Skilled in epidemiological literature review and data analysis.
Proficient in narrative writing for Clinical Study Reports (CSRs).
Strong attention to detail and ability to ensure data consistency across documents.
Excellent communication, project management, and organizational skills.
Perks & Benefits:
Remote work flexibility.
Exposure to global regulatory processes and document preparation.
Continuous professional development through mentorship and learning programs.
Collaborative, supportive, and inclusive work culture.
Opportunity to contribute to critical safety documentation impacting global health.
Company Description:
Parexel is a world-leading Contract Research Organization (CRO), specializing in clinical development and regulatory consulting services. Supporting global biopharmaceutical clients, Parexel is committed to patient safety, innovation, and scientific excellence in drug development and post-marketing activities.
Work Mode:
Remote (India)
Call to Action:
Advance your career as a Medical Writer specializing in pharmacovigilance and aggregate reporting. Apply now to become part of Parexel’s expert global safety team.
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