Назад
Company hidden
3 дня назад

Director, Medical Safety (Pharmacovigilance)

185 000 - 252 500$
Формат работы
remote (Global)
Тип работы
fulltime
Грейд
director
Английский
b2
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Director, Medical Safety (Pharmacovigilance): Leading pharmacovigilance activities across clinical development and post-marketing for products addressing serious and rare diseases with an accent on signal detection, risk management, aggregate safety reporting, and regulatory compliance. Focus on developing PV Scientists, evaluating benefit-risk profiles, supporting global regulatory requirements, and implementing AI-enabled tools to improve safety surveillance and operational efficiency.

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with travel of up to 15%.

Salary: $185,000–$252,500 annual.

Company

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

What you will do

  • Lead, mentor, and develop a team of Pharmacovigilance Scientists across products and development programs.
  • Oversee signal detection, evaluation, documentation, communication, and safety governance activities for investigational and marketed products.
  • Lead Risk Management Plans, risk minimization measures, Core Safety Information, Investigator’s Brochures, product labeling, and aggregate safety reports.
  • Provide pharmacovigilance support from first-in-human studies through post-marketing and contribute to benefit-risk assessments.
  • Partner with Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance.
  • Evaluate and implement AI-enabled tools for signal detection, literature surveillance, case review, reporting, data quality, and workflow optimization.

Requirements

  • Master’s degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline.
  • At least 10 years of experience in the pharmaceutical or biotechnology industry and at least 5 years of direct people management experience leading PV Scientists or Medical Safety professionals.
  • Experience supporting clinical development and post-marketing pharmacovigilance, including signal management, safety databases, Risk Management Plans, and aggregate safety reports.
  • Thorough knowledge of ICH guidelines and FDA, EMA, and global pharmacovigilance regulations.
  • Strong leadership, scientific, analytical, project management, communication, and stakeholder-influence skills.
  • Strong understanding of AI, automation, and advanced analytics applications in pharmacovigilance, with experience implementing innovative technologies.

Nice to have

  • Advanced scientific degree.
  • Experience in pulmonary disease, rare diseases, or gene therapy.
  • Experience with regulatory inspections, audits, global pharmacovigilance initiatives, safety data visualization, or signal detection methodologies.
  • Experience working in a matrixed global organization.

Culture & Benefits

  • Remote work with flexible schedules and purposeful in-person collaboration.
  • Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, and caregiver support.
  • 401(k) matching, annual equity awards, an Employee Stock Purchase Plan, and company-paid life and disability insurance.
  • Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →