3 дня назад
Medical Director, Drug Safety and Pharmacovigilance
268 000 - 331 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Director, Drug Safety and Pharmacovigilance (Oncology Pharmacovigilance): Leading medical review and clinical oversight of individual case safety reports across a global pharmacovigilance program with an accent on oncology safety assessment, vendor oversight, and regulatory compliance. Focus on evaluating adverse events, investigating quality deviations and CAPAs, supporting inspections and health authority inquiries, and providing medical input to safety and regulatory documents.
Location: South San Francisco, California; onsite four days per week, with work-from-home flexibility.
Salary: $268,000–$331,000 per year.
Company
is a public, clinical-stage precision medicine oncology company developing targeted therapies for genetically defined cancer patient populations.
What you will do
- Lead and oversee medical review of individual case safety reports, including complex and medically significant oncology cases.
- Assess adverse events for causality, seriousness, expectedness, and clinical accuracy of case narratives.
- Serve as the primary medical contact for the pharmacovigilance vendor and provide input on case quality, triage, and regulatory submission compliance.
- Monitor case-processing quality metrics, investigate deviations and quality events, and support CAPA development and tracking.
- Participate in vendor governance meetings and support regulatory inspections, audits, and health authority inquiries.
- Contribute to SOPs, medical review guidelines, training materials, aggregate safety reports, protocol amendments, investigator brochures, and informed consent documents.
Requirements
- MD or equivalent international medical degree with at least two years of bedside clinical experience.
- 5–8+ years of oncology experience in drug safety or pharmacovigilance.
- Strong hands-on experience with ICSR medical review.
- Experience working with external pharmacovigilance vendors or CROs.
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH requirements.
- Strong medical judgment, attention to detail, and ability to work effectively in a matrix environment.
Culture & Benefits
- Collaborative, inclusive, data-driven environment focused on advancing precision oncology therapies.
- Medical, dental, and vision coverage, with the company paying 100% for employees and 90% for dependents.
- 401(k), employee stock purchase plan, wellness programs, and eligibility for discretionary incentive and stock option awards.
- Employees working in company facilities must be fully vaccinated against COVID-19, subject to applicable accommodations.
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