LogoFresh Jobs Ahead
CooperCompanies
CooperCompanies
खाद्य और पेयपरामर्शस्वास्थ्य सेवा
CooperCompanies एक वैश्विक स्वास्थ्य सेवा कंपनी है, जो ऐसे चिकित्सा उपकरणों पर केंद्रित है जो जीवन के हर चरण में लोगों को स्वस्थ और बेहतर जीवन जीने में मदद करते हैं। अपने CooperVision और CooperSurgical व्यवसायों के माध्यम से, कंपनी दृष्टि देखभाल—जिसमें बचपन में होने वाली मायोपिया भी शामिल है—और प्रजनन स्वास्थ्य के लिए समाधान विकसित करती है, जिसमें बांझपन का सामना कर रहे लोगों और परिवारों के लिए सहायता भी शामिल है। CooperCompanies वर्तमान चिकित्सीय आवश्यकताओं और भविष्य के अवसरों को पूरा करने के लिए स्वास्थ्य सेवा पेशेवरों और मरीजों के विचारों को नवाचार तथा रणनीतिक निवेश के साथ जोड़ती है। इसके कार्य में स्थिरता संबंधी पहल और देखभाल के मानकों को बेहतर बनाने के प्रयास भी शामिल हैं, साथ ही व्यापक सामाजिक और पर्यावरणीय प्रभावों पर भी ध्यान दिया जाता है।
LinkedIn
कंपनी की नौकरियाँ

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.

USसंयुक्त राज्यCTकनेक्टिकट
$75,000 – $1,00,000 / वर्ष
रिमोटपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीकंटेंट लेखक

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • 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