3 дня назад
Associate Medical Director (Drug Safety)
141 500 - 268 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Medical Director (Drug Safety): Leading medical safety review of clinical trial serious adverse events and therapeutic-area activities with an accent on causality assessment, SUSAR company analyses, and pharmacovigilance. Focus on reviewing clinical and post-marketing safety cases, interpreting product and disease-state safety profiles, and supporting global regulatory processes, audits, and CAPA investigations.
Location: North Chicago, Illinois, United States; onsite role.
Base pay: $141,500–$268,500 annually.
Company
develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead medical safety review of serious adverse events from clinical trials.
- Perform causality assessments for clinical and post-marketing individual case safety reports.
- Develop company analyses for SUSARs and communicate findings accurately and promptly to clinical trial stakeholders.
- Provide leadership for an assigned therapeutic area and contribute to additional therapeutic-area activities.
- Support pharmacovigilance initiatives, controlled procedures, medical safety review training, audits, inspections, and CAPA investigations.
Requirements
- MD or equivalent medical degree.
- Associate Medical Director II: 1–2 years of drug safety experience with medical assessment and clinical case review.
- Knowledge of product and development-compound safety profiles, relevant therapeutic areas, disease states, and patient populations.
- Understanding of global regulations, processes, and practices.
- Must work at the North Chicago, Illinois location.
Culture & Benefits
- Paid vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) plan for eligible employees.
- Eligibility for long-term incentive programs.
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