CooperCompanies ir globāls veselības aprūpes uzņēmums, kas koncentrējas uz medicīnas ierīcēm, kuras palīdz cilvēkiem labi dzīvot visos dzīves posmos. Izmantojot savus CooperVision un CooperSurgical uzņēmumus, uzņēmums izstrādā redzes aprūpes risinājumus, tostarp risinājumus bērnu tuvredzības ārstēšanai, kā arī reproduktīvās veselības risinājumus, tostarp atbalstu cilvēkiem un ģimenēm, kas saskaras ar neauglību. CooperCompanies apvieno veselības aprūpes speciālistu un pacientu ieguldījumu ar inovācijām un stratēģiskām investīcijām, lai risinātu pašreizējās klīniskās vajadzības un izmantotu nākotnes iespējas. Uzņēmuma darbība ietver arī ilgtspējas iniciatīvas un centienus pilnveidot aprūpes standartus, vienlaikus ņemot vērā plašāku sociālo un vides ietekmi.
PSUR Writer II, Remote in Connecticut
Prepare compliant post-market safety reports for CooperSurgical fertility and women’s healthcare products. Analyze surveillance data and coordinate documentation with regulatory, clinical, quality, and risk teams.
Apraksts
- Prepare and maintain post-market surveillance plans and reports, including PSURs, for assigned product portfolios.
- Collect information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.
- Analyze post-market surveillance, complaint, vigilance, clinical, and risk data to produce compliant safety summaries and trend analyses.
- Support literature reviews and post-market surveillance work.
- Search public databases for adverse events, recalls, and competitor safety information.
- Collect data, perform quality checks, and conduct basic analyses for PSUR development.
- Review and analyze safety and performance data to support conclusions in PMSRs and PSURs.
- Maintain records in the Quality Management System.
- Flag schedule, quality, or data risks affecting assigned reports and share mitigation plans with management.
- Help develop and improve procedures, work instructions, templates, and guidance for PMS and PSUR activities.
- Find ways to improve the quality, consistency, and efficiency of PMS reporting documents.
- Keep documentation aligned with Quality Management System requirements and current regulatory expectations.
- Support EU MDR compliance work involving PMS documentation.
- Take part in cross-functional meetings and project discussions.
- Complete other assigned duties.
Prasības
- Communicate clearly in writing and verbally.
- Have a basic understanding of EU MDR, FDA regulations, and medical device vigilance requirements.
- Explain technical and scientific information clearly.
- Be organized and manage time effectively.
- Pay close attention to detail and review documents carefully.
- Use Microsoft Word, Excel, Teams, and SharePoint proficiently.
- Have a basic understanding of Quality Management Systems.
- Work effectively with cross-functional teams.
- Have at least 3 years of experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or a related medical device function.
- Experience supporting PMS Plans, PSURs, PMSRs, CERs, or similar regulatory documents is preferred.
- Hold a bachelor's degree in a scientific, technical, engineering, healthcare, or related field.
- Be able to sit for extended periods, especially at a computer.
- Be able to travel domestically and/or internationally 0–5% as needed.
Priekšrocības
- Medical coverage
- 401(k) plan
- Parental leave
- Fertility benefits
- Paid vacation, personal, sick, and holiday time
- Additional perks and benefits
- Potential eligibility for other compensation and benefits