7 дней назад
Periodic Reporting Expert
122 250 - 176 583$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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 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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