10 часов назад
Senior Manager, Global Case Management (Case Management Operations)
134 615 - 201 250$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Global Case Management (Case Management Operations) (Pharmacovigilance): Overseeing global ICSR case management operations, including internal workflows and outsourced PV vendor activities, with an accent on regulatory compliance, quality oversight, and safety reporting timelines. Focus on maintaining inspection readiness, optimizing safety databases and intake tools, and coordinating clinical and postmarketing safety deliverables.
Location: Princeton, New Jersey, United States
Salary: $134,615–$201,250 annually, plus incentive opportunity.
Company
is a pharmaceutical company developing and commercializing healthcare products and conducting clinical and postmarketing safety activities.
What you will do
- Provide subject matter expertise, operational guidance, and technical support for global case management activities.
- Oversee daily Individual Case Safety Report (ICSR) operations, quality monitoring, compliance, staffing coverage, and reporting timelines.
- Manage operational oversight of outsourced case processing performed by pharmacovigilance vendors.
- Collaborate with Clinical, Medical Safety, Data Management, Alliance Management, and Safety Data Management teams.
- Support clinical and postmarketing safety deliverables, including SAE reconciliation, protocol reviews, Safety Management Plans, and REMS activities.
- Support inspections, audits, CAPAs, process deviations, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; a health science, PharmD, RN, MPH, or advanced health-related degree is beneficial.
- At least 3 years of experience in pharmacovigilance, case management, or related drug safety functions.
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, CIOMS, and regional health authority requirements.
- Experience with global teams or large-scale pharmacovigilance operations and outsourced PV models.
- Experience supporting inspections and audits, including presenting, responding, and leading remediation efforts.
- Proficiency with safety databases, intake tools, PV systems, and system implementation or technology optimization initiatives.
Culture & Benefits
- Cross-functional collaboration in a global matrixed organization.
- Medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
- Tuition reimbursement, student loan assistance, and a generous 401(k) match.
- Flexible time off, paid holidays, and paid leave programs.
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