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3 дня назад

Associate Director, Drug Safety (Oncology)

164 000 - 205 000$
Формат работы
remote (только USA)
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, Drug Safety (Oncology) (Pharmacovigilance): Overseeing outsourced pharmacovigilance activities and coordinating safety deliverables for oral small-molecule oncology therapies with an accent on SAE processing, vendor performance, safety data reconciliation, and regulatory reporting. Focus on reviewing emerging safety trends, maintaining inspection-ready documentation, supporting audits and inspections, and coordinating safety processes across clinical development, clinical operations, and quality.

Location: Remote within the United States or onsite at the San Diego headquarters

Salary: $164K–$205K annually

Company

hirify.global Therapeutics is a clinical-stage life-science and technology company developing novel medicines through an AI-driven discovery and development platform.

What you will do

  • Oversee internally and externally performed serious adverse event processing activities.
  • Coordinate reconciliation of safety information across clinical databases and business partners.
  • Monitor pharmacovigilance vendor performance, compliance trends, deliverables, issues, and corrective actions.
  • Support safety database implementation, maintenance, and enhancement.
  • Contribute to aggregate safety reports, clinical and regulatory documents, regulatory submissions, and health authority responses.
  • Support safety management plans, audits, CAPAs, change controls, and regulatory inspections.

Requirements

  • Bachelor’s degree in nursing or pharmacy; an advanced degree such as PharmD, MSN, MPH, or equivalent is preferred.
  • At least 10 years of combined pharmacovigilance, drug safety, clinical science, or related experience with a bachelor’s degree, or 6–8 years with an advanced degree.
  • Experience in both safety science or surveillance and pharmacovigilance operations is preferred.
  • Strong knowledge of MedDRA and WHODrug dictionaries and proficiency with safety databases.
  • Knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GCP, and GVP requirements.
  • Excellent written, verbal, interpersonal, training, mentoring, and communication skills.

Nice to have

  • Oncology experience across Phase I–III development.

Culture & Benefits

  • AI-focused life-science environment advancing clinical-stage medicines.
  • Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
  • Uncapped vacation policy.
  • San Diego facility with an onsite gym and dining facilities.
  • Inclusive workplace focused on collaboration across diverse backgrounds and experiences.

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