PV Safety & Aggregate Reports Lead

Ipro Networks Pte. Ltd.; Cambridge (MA); Hybrid; USD 80,000 - 114,000; Full time

Job summary

IntelliPro seeks a PV Drug Safety Consultant to join our Hybrid Cambridge team. The role focuses on managing PSUR/DSUR/PADER and local reports across global safety programs, ensuring high-quality PV documentation.

You will collaborate with Safety, Clinical Development, Medical Affairs and Regulatory teams, interpreting data and guiding safety case evaluation with strong regulatory knowledge. A 5+ year PV background and a biological sciences degree are required.

Qualifications

• Bachelor's degree in biological or natural sciences required; advanced degree preferred.
• Minimum of 5 years of Pharmacovigilance experience including aggregate safety report writing and safety signal management.

Responsibilities

• Lead and conduct all aspects of substantive projects for PSURs, DSURs, PADERs and local reports.
• Act as expert on safety requirements, company policies and aggregate reporting processes.
• Support worldwide legislation reviews and provide impact assessments for aggregate reporting.
• Assist in authoring responses to safety inquiries from regulatory authorities with PV Scientists.
• Drive process improvements to enhance consistency in aggregate reporting and signal management.
• Maintain existing procedures and support rollout of new PV processes.

Skills

Data interpretation

Cross-functional collaboration

Clinical judgment

Regulatory & PV knowledge

Organizational independence

Technical proficiency

Education

Bachelor's degree in biological or natural sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

IntelliPro seeks a PV Drug Safety Consultant to join our Hybrid Cambridge team. The role focuses on managing PSUR/DSUR/PADER and local reports across global safety programs, ensuring high-quality PV documentation.

You will collaborate with Safety, Clinical Development, Medical Affairs and Regulatory teams, interpreting data and guiding safety case evaluation with strong regulatory knowledge. A 5+ year PV background and a biological sciences degree are required.