Назад
Company hidden
4 дня назад

Senior Manager, Global Patient Safety - General Medicine (Pharmacovigilance)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK/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
Senior Manager, Global Patient Safety - General Medicine (Pharmacovigilance): Developing and executing safety strategies for molecules in clinical development and post-marketing phases with an accent on signal detection, safety data analysis, and benefit-risk assessment. Focus on authoring regulatory safety documents, evaluating emerging signals, coordinating cross-functional safety activities, and applying FDA, EU, and ICH pharmacovigilance requirements.

Location: Uxbridge, UK, with 3 days per week on site

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for people with serious diseases.

What you will do

  • Develop and support global patient safety strategies for assigned molecules across clinical development and post-marketing phases.
  • Perform signal detection, evaluation, and preparation of safety evaluation reports.
  • Prepare and review DSUR, PSUR, RMP, and responses to health authority queries.
  • Present safety findings at Signal Management Team meetings and participate in clinical study team meetings.
  • Represent Global Patient Safety on cross-functional groups, including safety oversight and independent data monitoring committees.
  • Contribute to process improvements, SOPs, work instructions, and supporting safety documentation.

Requirements

  • Master’s degree, PhD, or PharmD required.
  • 7+ years of relevant risk management experience in the pharmaceutical or biotechnology industry or at a health authority.
  • Knowledge of FDA, EU, and ICH guidelines, initiatives, and regulations for clinical trial and post-marketing pharmacovigilance.
  • Experience working with a safety system database for medical case review and basic queries.
  • Proactive, self-disciplined approach with the ability to prioritize work and meet deliverables.
  • Strong verbal and written communication skills for communicating safety findings.

Culture & Benefits

  • Science-driven environment focused on developing life-changing medicines.
  • Inclusive workplace with equal employment opportunity and reasonable accommodation support.
  • Competitive total rewards package that may include bonuses, equity, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
  • Background checks may be conducted in accordance with the laws of the country where the position is based.

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 →