Lead PV Aggregate Reporting Scientist (Hybrid)

Pride Global; Cambridge (MA); Hybrid; USD 177,710,000 - 227,304,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) retirement savings

Life & disability insurance

Employee assistance program

Legal support

Pet insurance

Employee discounts

Job summary

Pride Global in Cambridge, MA is seeking a Pharmacovigilance professional on a 12-month contract to lead and author PSURs, DSURs, and related safety reports.

You will serve as an SME on global aggregate reporting requirements, manage schedules and timelines, and collaborate with PV, Clinical, Medical, Regulatory, Quality, and vendors to ensure compliant processes. Strong analytical and communication skills and 5+ years PV experience are required.

Qualifications

• Direct experience with aggregate 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

Data interpretation

Communication skills

Education

Bachelor's degree in Biological Sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Pride Global in Cambridge, MA is seeking a Pharmacovigilance professional on a 12-month contract to lead and author PSURs, DSURs, and related safety reports.

You will serve as an SME on global aggregate reporting requirements, manage schedules and timelines, and collaborate with PV, Clinical, Medical, Regulatory, Quality, and vendors to ensure compliant processes. Strong analytical and communication skills and 5+ years PV experience are required.