6 дней назад
Associate Director, DSPV Data, Technology and Innovation
164 000 - 213 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, DSPV Data, Technology and Innovation (Pharmacovigilance Technology and AI): Owning safety systems, the pharmacovigilance technology roadmap, analytics platforms, and AI use cases with an accent on system implementation, data migrations, regulatory compliance, and cross-functional delivery. Focus on evaluating AI pilots, designing safety dashboards, managing technology vendors, and ensuring data and systems support signal detection, benefit-risk evaluation, and global pharmacovigilance requirements.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected.
Salary: $164,000–$213,000 annual
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Own ’s pharmacovigilance safety systems, including safety databases, signal and risk management tools, reporting platforms, and analytics systems.
- Set the DSPV technology strategy and roadmap, evaluate new systems, secure funding, and manage technology projects from requirements through implementation and retirement.
- Lead safety data migrations, including data mapping, reconciliation, verification, legacy-system decommissioning, user acceptance testing, training, and cutover.
- Define DSPV reporting and analytics requirements, own dashboards and metric definitions, and partner with data platform teams on data quality, access, and reporting standards.
- Identify and manage AI use cases for pharmacovigilance, establish pilot success criteria, evaluate performance, and recommend whether solutions should scale, change, or stop.
- Collaborate with IT, Quality Assurance, Regulatory Affairs, Clinical Development, Epidemiology, Biostatistics, vendors, and health authorities on system delivery, validation, compliance, and inspections.
Requirements
- Bachelor’s degree in a scientific, computational, health-related, or information systems discipline; an advanced degree is preferred.
- At least 7 years of experience in a biotech or pharmaceutical company, including at least 5 years working with pharmacovigilance systems, safety data, or PV analytics.
- Experience as a business owner, system owner, or business lead for an industry-standard safety database such as Oracle Argus, ArisGlobal LifeSphere/ARISg, or Veeva Vault Safety.
- Experience implementing safety systems, leading safety data migrations, managing technology projects, and working with technology vendors.
- Experience with computer system validation, user acceptance testing, change control, MedDRA coding, E2B standards, and global PV regulations including ICH E2A–E2F and GVP modules.
- Understanding of AI and data systems, including data pipelines, integrations, model evaluation, performance monitoring, and acceptance criteria; familiarity with Snowflake, Qlik, Power BI, Tableau, and SQL.
Nice to have
- Practical experience with AI, machine learning, natural language processing, or real-world evidence in pharmacovigilance or clinical development.
- Working knowledge of R, Python, or SAS.
- Experience presenting or publishing pharmacovigilance technology and AI work at industry forums.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and minimal travel.
- Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and Employee Assistance Program access.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
- Learning programs, mentorship, networking opportunities, employee resource groups, service programs, and recognition initiatives.
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