3 дня назад
Associate Director, Drug Safety (Oncology)
164 000 - 205 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Drug Safety (Oncology) (Pharmacovigilance): Overseeing outsourced pharmacovigilance activities and coordinating safety deliverables for oral small-molecule oncology therapies with an accent on SAE processing, vendor performance, safety data reconciliation, and regulatory reporting. Focus on reviewing emerging safety trends, maintaining inspection-ready documentation, supporting audits and inspections, and coordinating safety processes across clinical development, clinical operations, and quality.
Location: Remote within the United States or onsite at the San Diego headquarters
Salary: $164K–$205K annually
Company
Therapeutics is a clinical-stage life-science and technology company developing novel medicines through an AI-driven discovery and development platform.
What you will do
- Oversee internally and externally performed serious adverse event processing activities.
- Coordinate reconciliation of safety information across clinical databases and business partners.
- Monitor pharmacovigilance vendor performance, compliance trends, deliverables, issues, and corrective actions.
- Support safety database implementation, maintenance, and enhancement.
- Contribute to aggregate safety reports, clinical and regulatory documents, regulatory submissions, and health authority responses.
- Support safety management plans, audits, CAPAs, change controls, and regulatory inspections.
Requirements
- Bachelor’s degree in nursing or pharmacy; an advanced degree such as PharmD, MSN, MPH, or equivalent is preferred.
- At least 10 years of combined pharmacovigilance, drug safety, clinical science, or related experience with a bachelor’s degree, or 6–8 years with an advanced degree.
- Experience in both safety science or surveillance and pharmacovigilance operations is preferred.
- Strong knowledge of MedDRA and WHODrug dictionaries and proficiency with safety databases.
- Knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GCP, and GVP requirements.
- Excellent written, verbal, interpersonal, training, mentoring, and communication skills.
Nice to have
- Oncology experience across Phase I–III development.
Culture & Benefits
- AI-focused life-science environment advancing clinical-stage medicines.
- Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
- Uncapped vacation policy.
- San Diego facility with an onsite gym and dining facilities.
- Inclusive workplace focused on collaboration across diverse backgrounds and experiences.
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