Remote PV Aggregate Reporting Specialist

IntelliPro Group; Cambridge (MA); Remote; USD 90,000 - 129,000; Full time

Job summary

IntelliPro seeks a Drug Safety Consultant to work remotely on EST; a 12-month engagement with potential extension. You will manage aggregate reports (PSURs, DSURs, PADERs) and coordinate with Safety, Regulatory, and Clinical teams to ensure high-quality PV deliverables.

The role demands pharmacovigilance experience, data interpretation, and strong collaboration with vendors and internal stakeholders. Pay is $79.61/hr on W2.

Qualifications

• Data interpretation of scientific data and medical terminology.
• Cross-functional collaboration across Safety, Clinical Development, and Regulatory.
• Strong clinical judgment in case data evaluation.
• Knowledge of pharmacovigilance and post-marketing safety regulations.
• Organized with independence to prioritize tasks.
• Proficiency in Excel, PowerPoint, Word and safety databases.

Responsibilities

• Lead and conduct aggregate reporting projects (PSURs, DSURs, PADERs, local reports).
• Act as expert on safety requirements and cross-functional processes.
• Support worldwide regulatory oversight and schedule management.
• Assist with responses to safety inquiries from regulatory authorities.
• Drive process improvements for consistency in PV reporting.
• Implement and maintain PV procedures and new processes.

Skills

Data interpretation

Collaboration

Clinical judgment

PV knowledge

Organization

Excel basics

Safety databases

Education

Bachelor’s degree in biological or natural sciences

Advanced degree preferred

Tools

Excel

PowerPoint

Word

Business Objects

Job description

IntelliPro seeks a Drug Safety Consultant to work remotely on EST; a 12-month engagement with potential extension. You will manage aggregate reports (PSURs, DSURs, PADERs) and coordinate with Safety, Regulatory, and Clinical teams to ensure high-quality PV deliverables.

The role demands pharmacovigilance experience, data interpretation, and strong collaboration with vendors and internal stakeholders. Pay is $79.61/hr on W2.