3 дня назад
Temp Mgr Global Patient Safety Sciences
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Temp Mgr Global Patient Safety Sciences (Pharmacovigilance): Developing 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 DSUR, PSUR, and RMP documents, evaluating safety signals, and coordinating risk management activities across clinical and regulatory teams.
Location: Tarrytown, New York, United States; onsite expectations apply
Company
is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.
What you will do
- Develop safety strategies for molecules in clinical development and post-marketing phases.
- Perform signal detection and evaluate identified safety signals according to approved surveillance plans.
- Author and review safety documents, including DSUR, PSUR, RMP, and responses to health authority queries.
- Prepare and deliver presentations for 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.
- Support safety data manipulation, visualization, risk management activities, and process improvement initiatives.
Requirements
- Master of Science, PhD, or PharmD degree.
- At least 5 years of risk management or relevant clinical experience in the pharmaceutical or biotechnology industry, or at a health authority.
- Previous safety or relevant clinical experience in the pharmaceutical industry.
- Experience with data manipulation and visualization using Excel and pivot tables.
- Ability to work onsite in Tarrytown, New York, United States.
Nice to have
- Clinical or industry experience in the relevant therapeutic area.
Culture & Benefits
- Inclusive workplace and equal employment opportunity environment.
- Competitive total rewards package that may include bonuses, equity awards, retirement benefits, insurance, paid time off, and family support benefits.
- Reasonable accommodation available during the recruitment process where required.
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