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2 дня назад

Associate Director, Pharmacovigilance/Product Safety (Pharmacovigilance)

164 000 - 213 000$
Формат работы
remote (Global)
Тип работы
fulltime
Грейд
director
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
Associate Director, Pharmacovigilance/Product Safety (Pharmacovigilance): Evaluating medical safety and risk for biopharmaceutical products across clinical development and post-marketing with an accent on adverse-event assessment, benefit-risk analysis, and regulatory documentation. Focus on investigating emerging safety data, maintaining risk management plans, reviewing case narratives, and supporting safety oversight across the product life cycle.

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, up to 10% annually. The posting also lists Bridgewater, New Jersey, United States as the company location.

Salary: $164,000–$213,000 annually

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Provide medical expertise for safety and risk assessment across clinical development and post-marketing activities.
  • Assess the medical significance and expectedness of adverse-event and serious-adverse-event reports and approve case narratives.
  • Compile analyses of similar events, individual cases, risk management plans, and ad hoc safety data.
  • Investigate emerging safety information from clinical trials, spontaneous reports, literature, aggregate reports, toxicology, and non-clinical studies.
  • Author, review, and approve drug-safety regulatory reports and clinical documents, including protocols, investigator brochures, integrated safety summaries, MedDRA coding, and product labeling.
  • Collaborate with safety vendors and participate in internal safety review committee meetings.

Requirements

  • Master’s degree in life sciences, RN, PharmD, or MD.
  • At least 3–5 years of experience as a safety officer or in a similar pharmacovigilance leadership role in the pharmaceutical industry.
  • Strong experience managing safety information from clinical development and post-marketing sources.
  • Expert knowledge of pharmacovigilance regulations and working knowledge of industry-standard pharmacovigilance databases and MedDRA.
  • Strong leadership, communication, organization, attention to detail, clarity, accuracy, and conciseness.
  • Device experience is strongly preferred.

Culture & Benefits

  • Fully remote work with purposeful in-person collaboration and occasional team travel.
  • Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
  • 401(k) with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
  • Learning resources, leadership programs, mentorship, employee resource groups, and service and recognition programs.

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