PV Aggregate Reporting Scientist (Hybrid, Cambridge)

Russell Tobin; Cambridge (MA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

PrideGlobal and its affiliates partner with a global pharmaceutical organization to identify a PV Aggregate Report Scientist for a Cambridge, MA hybrid role.

The candidate will lead PSUR/DSUR/PADER reporting, serve as PV SME, and manage schedules with cross-functional teams to meet regulatory timelines. A strong pharmacovigilance background and expertise in safety signals are required.

Qualifications

• 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; familiarity with PV safety databases.
• Education: Bachelor's degree in Biological Sciences, Natural Sciences, or related field; advanced degree preferred.
• Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
• Safety report writing and safety signal management.

Responsibilities

• Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as a Subject Matter Expert 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.

Skills

Safety report writing

Safety signal management

PSUR/DSUR knowledge

Regulatory knowledge

Education

Bachelor's degree in Biological/Natural Sciences or related field

Advanced degree (MSc/PhD/ MPH/ PharmD) preferred

Tools

Excel

PowerPoint

Word

Business Objects

PV databases

Job description

PrideGlobal and its affiliates partner with a global pharmaceutical organization to identify a PV Aggregate Report Scientist for a Cambridge, MA hybrid role.

The candidate will lead PSUR/DSUR/PADER reporting, serve as PV SME, and manage schedules with cross-functional teams to meet regulatory timelines. A strong pharmacovigilance background and expertise in safety signals are required.