PSUR Writer

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Remote in US

Job Summary:

The PSUR Writer II is responsible for the preparation, maintenance, and timely completion of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) to ensure compliance with global regulatory requirements. The role collaborates cross-functionally to gather relevant safety, clinical, complaint, vigilance, and risk management information; evaluates and summarizes data; and ensures documentation is completed in accordance with applicable regulatory requirements and internal timelines. The PSUR Writer II contributes to process improvements, supports the development of departmental procedures and templates, and serves as a knowledgeable resource for post-market surveillance documentation activities.

Responsibilities

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios.

• Gather and compile information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.

• Analyze and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to develop regulatory-compliant safety summaries and trend analyses.

• Support literature reviews and post-market surveillance activities.

• Conduct public database searches for adverse events, recalls, and competitor safety information.

• Perform data collection, quality checks, and basic analysis to support PSUR development.

• Review, trend, and analyze relevant safety and performance data to support conclusions documented within PMSRs and PSURs.