Aggregate Safety Reporting Specialist

Planet Pharma; Cambridge (MA); On-site; USD 117,000 - 131,000; Full time

Job summary

Planet Pharma in the United States seeks an experienced PV professional to lead aggregate safety reporting activities, coordinating with cross-functional teams and regulatory partners to ensure timely and compliant PSURs, DSURs, and line listings.

The role involves overseeing line listing management, developing SMPs/ESRPs, driving process improvements, supporting safety committees, and mentoring staff in pharmacovigilance best practices across global regions.

Qualifications

• Minimum 3–5 years in pharmaceutical industry with drug safety/pharmacovigilance experience.

Responsibilities

• Lead authoring of aggregate safety reports (PSUR, DSUR, Line listings).
• Oversee line listings management for PV Science group and submissions.
• Develop SMPs/ESRPs with regulatory teams and stakeholders.
• Identify gaps in aggregate report processes and drive changes.
• Collaborate on signaling and data mining using multiple data sources.
• Provide training and guidance to new staff in safety practices.

Skills

Pharmacovigilance

Safety reporting

Data analysis

Cross-functional collaboration

Regulatory knowledge

Dashboard development

Education

Medical or healthcare related degree

Tools

Argus

Arisg Safety Databases

Empirica

Spotfire

Job description

Planet Pharma in the United States seeks an experienced PV professional to lead aggregate safety reporting activities, coordinating with cross-functional teams and regulatory partners to ensure timely and compliant PSURs, DSURs, and line listings.

The role involves overseeing line listing management, developing SMPs/ESRPs, driving process improvements, supporting safety committees, and mentoring staff in pharmacovigilance best practices across global regions.