PV Aggregate Reports Scientist (Hybrid)

Pride Health; Cambridge (MA); Hybrid; USD 96,000 - 107,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) retirement plan

Life & disability insurance

Employee discounts

Job summary

Pride Health is seeking a PV Aggregate Reports Scientist for a hybrid contract in Cambridge, MA. The role focuses on leading the preparation of PSURs, DSURs, PADERs, and other aggregate safety reports within the SSA team.

The candidate should have at least 5 years of Pharmacovigilance experience, strong knowledge of regulatory reporting, and proficiency with PV databases and MS Office tools. Collaborative, cross-functional work is essential.

Qualifications

• 5+ years of Pharmacovigilance experience, including aggregate safety report writing.
• Experience with global aggregate reporting requirements and PV processes.
• Knowledge of PSUR, PBRER, DSUR and local reporting requirements.

Responsibilities

• Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as 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 and PV process improvements.

Skills

Aggregate safety reports

Safety signal management

PSUR/PBRER

DSUR

Regulatory reporting

Data interpretation

PV processes

Education

Bachelor's degree in Biological/Natural Sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Pride Health is seeking a PV Aggregate Reports Scientist for a hybrid contract in Cambridge, MA. The role focuses on leading the preparation of PSURs, DSURs, PADERs, and other aggregate safety reports within the SSA team.

The candidate should have at least 5 years of Pharmacovigilance experience, strong knowledge of regulatory reporting, and proficiency with PV databases and MS Office tools. Collaborative, cross-functional work is essential.