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7 дней назад

Periodic Reporting Expert

122 250 - 176 583$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Periodic Reporting Expert (Pharmacovigilance): Coordinating and delivering global periodic safety reports, including PSURs, PBRERs, and DSURs, with an accent on regulatory compliance, scientific rigor, and cross-functional collaboration. Focus on authoring health authority responses, improving reporting automation and efficiency, and mentoring internal teams and vendors on ICH and GVP requirements.

Location: Morristown, New Jersey; US and Puerto Rico residents only

Salary: $122,250–$176,583 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines, vaccines, medical devices, and diagnostics, supported by AI, data, and digital platforms.

What you will do

  • Act as a subject matter expert on global regulatory frameworks and pharmacovigilance practices for periodic safety reporting.
  • Coordinate PSUR, PBRER, and DSUR preparation across internal teams and external partners.
  • Ensure timely, high-quality, and compliant regulatory submissions.
  • Author and contribute to health authority responses concerning periodic reporting.
  • Drive automation, efficiency, quality, and continuous improvement across the reporting lifecycle.
  • Provide training and mentorship to vendors, collaborators, and global partners.

Requirements

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Physics, or a related scientific field; PharmD or another healthcare professional degree is also accepted.
  • For BS holders: at least 3 years of industry experience, including 1 year in pharmacovigilance.
  • For PharmD and other healthcare professional degree holders: at least 2 years of clinical or industry experience, including 1 year in pharmacovigilance.
  • Strong knowledge of ICH and GVP guidelines and their application to periodic safety reporting.
  • Proficiency in Microsoft Office and hirify.global systems, including Viva and Workday.
  • Project management, collaboration, adaptability, and experience leading cross-functional meetings in English.

Culture & Benefits

  • Supportive, future-focused environment centered on patient safety and scientific progress.
  • Career growth opportunities through promotions and international or lateral moves.
  • Company rewards and employee benefit programs.
  • Healthcare, prevention, wellness programs, and at least 14 weeks of gender-neutral parental leave.
  • Opportunity to work with AI, data, and digital platforms in drug discovery and development.

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