8 дней назад
Director, Drug Safety (Pharmacovigilance)
247 300 - 280 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Drug Safety (Pharmacovigilance): Leading aggregate safety analysis, benefit–risk assessments, and safety strategy for clinical programs developing targeted protein degradation medicines with an accent on signal detection, regulatory safety documentation, and clinical development support. Focus on interpreting complex safety data, shaping risk mitigation strategies, and coordinating global pharmacovigilance decisions with clinical, regulatory, and medical affairs stakeholders.
Location: Onsite – Brisbane, California, United States
Salary: $247,300–$280,400 for non-MD candidates; $295,000–$317,100 for MD candidates. The posted range applies to roles based in the San Francisco Bay Area.
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases, supported by an AI-integrated discovery engine.
What you will do
- Lead medical safety strategy and aggregate safety analysis for assigned clinical programs.
- Evaluate safety signals, characterize risks, and contribute to benefit–risk assessments.
- Oversee medical review of Individual Case Safety Reports and prepare DSURs, IND safety sections, and regulatory briefing materials.
- Provide safety input into clinical trial protocols, informed consent forms, and investigator brochures.
- Support regulatory authority responses, inspections, audits, and global safety strategy.
- Participate in safety governance committees and collaborate across clinical development, regulatory affairs, and medical affairs.
Requirements
- Advanced clinical or scientific degree such as MD, DO, PharmD, or equivalent relevant training and experience.
- 5–10 years of pharmaceutical or biotechnology experience in pharmacovigilance or drug safety.
- Expertise in aggregate safety analysis and benefit–risk evaluation.
- Knowledge of global pharmacovigilance regulations and guidance, including ICH, FDA, EMA, and MHRA.
- Experience with early clinical development, safety surveillance tools and databases, and global health authority interactions.
- Ability to work onsite in Brisbane, California.
Culture & Benefits
- Highly collaborative, team-oriented working environment.
- Solutions- and results-oriented approach.
- Hands-on, resourceful culture open to diverse points of view.
- Opportunity to influence safety decisions for targeted protein degradation therapies across the clinical pipeline.
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