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7 дней назад

Senior Global Safety Partnership Oversight Manager / Associate Global Safety Partnership Oversight Director (Pharmacovigilance)

145 500 - 190 000$
Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
Релокация
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Senior Global Safety Partnership Oversight Manager / Associate Global Safety Partnership Oversight Director (Pharmacovigilance): Overseeing global partner safety-data exchange, ICSR case management, reconciliation, compliance, and inspection readiness with an accent on pharmacovigilance governance, regulatory requirements, and patient-safety reporting. Focus on evaluating complex compliance issues, leading risk-based corrective actions, and improving partnership oversight across affiliates, alliances, and QPPVs.

Location: Remote within the continental United States, with a preference for candidates residing in or willing to relocate to RTP, NC. Local candidates work from the Durham, NC office on a hybrid schedule of 3 days in the office and 2 days from home.

Salary: $145,500–$190,000 for the Senior Global Safety Partnership Oversight Manager level; $167,500–$205,000 for the Associate Global Safety Partnership Oversight Director level.

Company

hirify.global is a publicly traded biotechnology and pharmaceutical company developing therapies for rare diseases and technologies intended to expand the availability of transplantable organs.

What you will do

  • Oversee partner-related safety data exchange, case management, reconciliation, reporting quality, and compliance activities.
  • Monitor global pharmacovigilance regulations and provide guidance on operational implementation.
  • Evaluate complex ICSR, governance, regulatory, inspection, and compliance issues and recommend risk-based solutions.
  • Serve as the escalation point and subject matter expert for affiliates, business partners, alliances, and QPPVs.
  • Lead cross-functional initiatives that improve partnership oversight, reporting quality, process efficiency, and inspection readiness.
  • Support audits and inspections, root-cause analyses, deviations, and corrective and preventive actions.

Requirements

  • Bachelor’s degree in chemistry, biology, or a related field.
  • At least 10 years of pharmacovigilance and end-to-end ICSR case-processing experience for the Manager level, or at least 12 years for the Associate Director level, with alternative thresholds for master’s or PharmD qualifications.
  • At least 4 years of QPPV or deputy QPPV experience for the Manager level, or at least 6 years in a related function for the Associate Director level.
  • Experience with safety data exchange, adverse-event reporting, pharmacovigilance agreements, quality systems, reconciliation, and CAPA processes.
  • Advanced knowledge of global pharmacovigilance regulations, post-marketing surveillance, and regulatory reporting obligations.
  • Experience with safety databases and supporting technologies, preferably Argus, plus project leadership and stakeholder-management skills.

Nice to have

  • Master’s degree in chemistry, biology, or a related field.
  • Doctor of Pharmacy degree.

Culture & Benefits

  • Medical, dental, vision, and prescription coverage.
  • Wellness resources, 401(k), and employee stock purchase plan.
  • Paid time off, paid parental leave, and disability benefits.
  • Remote work is available within the continental United States; local employees follow a hybrid schedule.

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