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# PV Aggregate Report Scientist

- **Company:** Pride Global
- **Location:** Cambridge, MA, United States
- **Experience:** Expert
- **Salary:** $128,960 - $165,360
- **Contract:** Temporary contract
- **Skills:** Microsoft Word, Microsoft Excel, Clinical Trial Management Systems, Databases, Microsoft PowerPoint, Sap Business Objects
- **Published:** November 6, 2026
- **Apply:** https://www.careerbuilder.com/job-details/pv-aggregate-report-scientist-cambridge-ma--7ab9e208-a6c4-4ed1-82b2-18ef85c87f44

## About the Role

Biotech and Pharmaceutical, Writing Skills, Regulations, Schedule Development, Process Improvement, Clinical Trial Management, Pharmacovigilance, Clinical Monitoring, Reporting Skills, Clinical Trial, * Direct experience with aggregate safety report writing and safety signal management.

 * Strong knowledge of PSUR/PBRER, DSUR, PADER, and local reporting requirements.
 * Knowledge of clinical trial and post-marketing safety regulations, case processing, expedited reporting, and safety databases.
 * Strong scientific/medical data interpretation and communication skills.
 * Proficiency with Excel, PowerPoint, Word, Business Objects, and familiarity with PV safety databases.
 * Education: Bachelor's degree in Biological Sciences, Natural Sciences, or related field; advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
 * Years of experience: Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
 * Skills/Specialties/Technology: Safety report writing and safety signal management.

## Description

* Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
 * Serve as a Subject Matter Expert (SME) on global aggregate reporting requirements and PV processes.
 * Manage aggregate report schedules, stakeholder reviews, and regulatory timelines.
 * Conduct global regulatory/legislation reviews and provide impact assessments.
 * Support Health Authority responses to safety inquiries.
 * Collaborate with PV, Clinical, Medical, Regulatory, Quality, and external vendors.
 * Support signal management, clinical trial safety oversight, and PV process improvements.
 * Maintain and implement compliant global PV procedures and processes.