US Drug Safety Consultant II - Aggregate Reports Lead

TalentBurst, an Inc 5000 company; Cambridge (MA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

TalentBurst, Cambridge (Hybrid) seeks a US Drug Safety Consultant II to manage worldwide aggregate reporting for PSURs, DSURs, PADERs and local reports. The role requires 5+ years in pharmacovigilance and expertise in safety data, processes, and regulatory guidance.

The position focuses on leading reports, authoring safety content, coordinating with cross-functional teams, and improving processes to ensure compliant, timely submissions.

Qualifications

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

Responsibilities

• Lead and conduct all aspects of substantive projects for PSURs, DSURs, PADERs and local reports.
• Act as expert on safety requirements and aggregate reporting; represent processes in cross-functional forums.
• Support worldwide regulatory reviews, impact assessments and master schedule maintenance.
• Assist with safety inquiries responses alongside PV Scientists and stakeholders.
• Drive process improvements for 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

Organization & independence

Technical proficiency

Education

Bachelor's degree in biological or natural sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

TalentBurst, Cambridge (Hybrid) seeks a US Drug Safety Consultant II to manage worldwide aggregate reporting for PSURs, DSURs, PADERs and local reports. The role requires 5+ years in pharmacovigilance and expertise in safety data, processes, and regulatory guidance.

The position focuses on leading reports, authoring safety content, coordinating with cross-functional teams, and improving processes to ensure compliant, timely submissions.