7 дней назад
Senior Director, DSPV Quality, Training & Compliance (Pharmacovigilance)
222 000 - 303 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, DSPV Quality, Training & Compliance (Pharmacovigilance): Overseeing the global drug safety and pharmacovigilance quality and compliance framework with an accent on compliance monitoring, inspection readiness, training governance, and CAPA management. Focus on analyzing PV system metrics, leading audit and inspection preparation, managing deviations and remediation, and driving continuous improvement across global pharmacovigilance operations.
Location: Fully remote; can be performed from anywhere. Occasional domestic travel for leadership team meetings is expected, approximately 5–10%.
Salary: $222,000–$303,000 annual.
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Oversee and continuously improve the DSPV quality and compliance monitoring framework.
- Establish compliance standards, KPIs, quality metrics, dashboards, and trend analysis for the PV system.
- Lead DSPV training governance, competency development, and training compliance.
- Govern the lifecycle of DSPV SOPs, work instructions, standards, and controlled documents.
- Coordinate preparation for regulatory inspections, audits, and due diligence assessments.
- Manage quality events, deviations, audit findings, inspection observations, CAPAs, root cause analysis, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in a life sciences discipline.
- 10+ years of experience in pharmacovigilance, including 3+ years in a quality or compliance leadership role.
- Experience managing global pharmacovigilance inspections conducted by major health authorities.
- Deep knowledge of global PV regulations and guidelines, including FDA, EMA, and ICH.
- Strong experience building and leading teams in a fast-paced environment.
- Experience in a small or mid-size biopharmaceutical company.
Nice to have
- Advanced degree such as MS, PharmD, or PhD.
- Experience in both clinical-stage and commercial-stage environments.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and occasional travel.
- Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, service programs, and recognition opportunities.
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