Назад
Company hidden
7 дней назад

Global Pharmacovigilance Senior Medical Director (Pharmacovigilance)

320 000 - 400 000$
Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
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
Global Pharmacovigilance Senior Medical Director (Pharmacovigilance): Leading medical and scientific drug-safety strategy across an immunology and inflammation pipeline, including benefit-risk evaluation, signal assessment, regulatory submissions, and safety governance with an accent on pharmacovigilance leadership for clinical trials and biologic therapies. Focus on designing risk management plans, interpreting global safety regulations, integrating real-world safety evidence, and guiding complex decisions with Health Authorities, Data Safety Monitoring Boards, and cross-functional teams.

Location: Remote, with periodic travel to hirify.global offices for in-person collaboration and business operations. Work arrangements and benefits vary by the country or region of hire.

Salary: $320,000–$400,000 USD per year, plus potential annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

  • Lead medical and scientific pharmacovigilance strategy across the immunology and inflammation pipeline.
  • Set standards for ICSR review, aggregate safety analysis, signal evaluation, benefit-risk assessment, and interpretation of clinical, spontaneous, literature, and real-world safety data.
  • Provide medical oversight for pharmacovigilance vendors and safety evaluation outputs.
  • Lead safety strategy for clinical trials, DSMB interactions, risk mitigation, regulatory submissions, label negotiations, and Health Authority communications.
  • Own or direct Risk Management Plans, REMS programs, risk minimization measures, and effectiveness assessments.
  • Mentor pharmacovigilance personnel and collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Medical Writing, and Clinical Operations.

Requirements

  • MD or DO degree required.
  • 10+ years of combined clinical and pharmaceutical or biotechnology industry experience, including 8–10 years of dedicated pharmacovigilance or drug safety experience in a senior medical role.
  • Previous Director-level or equivalent experience and a track record as physician-of-record for pharmacovigilance programs across multiple compounds or indications.
  • Authoritative knowledge of FDA guidance, EU GVP Modules I–XVI, ICH guidelines, IND and NDA/BLA safety content, and integrated safety summaries.
  • Experience with Risk Management Plans, REMS programs, biologics safety in immunology, and outsourced pharmacovigilance oversight.
  • Periodic travel to company offices is required for in-person collaboration and business operations.

Nice to have

  • Board certification in immunology, rheumatology, internal medicine, or a related specialty.
  • Clinical experience in autoimmune disease and immunology and inflammation experience.
  • Experience building or shaping a pharmacovigilance function in an early- or mid-stage biotechnology company.

Culture & Benefits

  • Remote work arrangement with periodic in-person collaboration.
  • Flexible work arrangements and hybrid scheduling.
  • Health and wellness coverage, with structure varying by country.
  • Paid time off, public holidays, and additional leave in accordance with local requirements.
  • Potential annual bonus and long-term incentive award based on performance.

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 →