4 дня назад
Senior Manager, Global Patient Safety - General Medicine (Pharmacovigilance)
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
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 →
Похожие вакансии
6 дней назад
Associate Director, Pharmacovigilance/Product Safety
6 дней назад
Director, Drug Safety & Pharmacovigilance Scientist
220 000 - 240 000$
7 дней назад
Global Pharmacovigilance Senior Medical Director (Pharmacovigilance)
320 000 - 400 000$
7 дней назад
Senior Director, Clinical Safety MD
280 350 - 467 250$
6 дней назад
Director, Medical Safety (AI)
4 дня назад
Global Safety Officer, I&I
178 500 - 297 500$