PV Aggregate Report Scientist

Join a top-tier global biopharmaceutical leader as a PV Aggregate Reports Scientist on the Safety Surveillance and Aggregate (SSA) Reports team. This contract role is based in Cambridge, Massachusetts, with standard 9-to-5 work hours and a pay range of $65–77 per hour.

Responsibilities

• Independently author, project manage, and oversee PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as the global subject matter expert on safety requirements, providing guidance across cross-functional teams.
• Monitor global pharmacovigilance legislation updates, conduct impact assessments, and maintain the Aggregate Reports Master Schedule.
• Support authoring responses to regulatory authority safety inquiries in collaboration with PV Scientists and key stakeholders.
• Lead process improvement initiatives to enhance aggregate reporting, signal management, and safety oversight efficiency.

Requirements

• Bachelor’s degree in biological or natural sciences.
• Minimum of 5 years of Pharmacovigilance experience, including direct experience writing aggregate safety reports and managing safety signals.
• Strong knowledge of drug safety regulations, clinical trial safety, and post-marketing safety processes.
• Proven ability to analyze and present complex medical data clearly to cross-functional partners.
• Experience with safety database systems and standard office software.

Qualifications

Preferred: Advanced degree (MSc, PhD, MPH, PharmD, or equivalent).

Skills

• Pharmacovigilance
• Drug Safety
• Development Safety Update Report (DSUR)
• Periodic Adverse Drug Experience Report (PADER)
• Periodic Safety Update Report (PSUR)

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability coverage
• 401K plan

Pay

$65–77 per hour.

Schedule

9 to 5.