6 дней назад
Senior Safety Data Scientist (Pharmacovigilance)
124 500 - 236 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Safety Data Scientist (Pharmacovigilance): Supporting product safety and benefit-risk evaluation throughout the product lifecycle with an accent on signal detection, signal assessment, and regulatory safety reporting. Focus on analyzing clinical trial, safety database, and literature data, evaluating patient-safety risks, and communicating findings to product teams, senior management, and regulatory authorities.
Location: Irvine, California, United States
Salary: $124,500–$236,500 USD annually
Company
develops medicines and healthcare solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.
What you will do
- Conduct standard product safety surveillance using clinical trial, safety database, and literature data.
- Develop signal assessment strategies with safety and clinical teams and respond to regulatory requests.
- Analyze data from multiple sources to evaluate safety signals and their impact on product benefit-risk profiles.
- Communicate surveillance findings and recommend risk minimization activities, including label changes.
- Prepare and maintain safety sections for clinical summaries, clinical study reports, core data sheets, and risk management plans.
- Support global aggregate safety reports and prepare safety summaries for leadership, advisory, and safety review meetings.
Requirements
- Degree in a health science such as pharmacy, epidemiology, or nursing.
- Bachelor’s degree plus at least 2 years of clinical, pharmaceutical, or safety experience; or a master’s/doctoral degree plus 1–2 years of relevant experience.
- Knowledge of drug development, clinical trials, regulatory submissions, product launch, and post-marketing support.
- Proficiency in pharmacovigilance regulations, guidelines, and standard operating procedures.
- Ability to work in multidisciplinary matrix teams, manage multiple projects, communicate effectively, and work independently with guidance.
- Microsoft Word, Excel, and basic project management skills.
Culture & Benefits
- Cross-functional collaboration with safety, clinical, product, and leadership teams.
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) and eligibility for long-term incentive programs.
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