Senior Global Safety Partnership Oversight Manager / Associate Global Safety Partnership Oversight Director (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote within the continental United States, with a preference for candidates residing in or willing to relocate to RTP, NC. Local candidates work from the Durham, NC office on a hybrid schedule of 3 days in the office and 2 days from home.
Salary: $145,500–$190,000 for the Senior Global Safety Partnership Oversight Manager level; $167,500–$205,000 for the Associate Global Safety Partnership Oversight Director level.
Company
is a publicly traded biotechnology and pharmaceutical company developing therapies for rare diseases and technologies intended to expand the availability of transplantable organs.
What you will do
- Oversee partner-related safety data exchange, case management, reconciliation, reporting quality, and compliance activities.
- Monitor global pharmacovigilance regulations and provide guidance on operational implementation.
- Evaluate complex ICSR, governance, regulatory, inspection, and compliance issues and recommend risk-based solutions.
- Serve as the escalation point and subject matter expert for affiliates, business partners, alliances, and QPPVs.
- Lead cross-functional initiatives that improve partnership oversight, reporting quality, process efficiency, and inspection readiness.
- Support audits and inspections, root-cause analyses, deviations, and corrective and preventive actions.
Requirements
- Bachelor’s degree in chemistry, biology, or a related field.
- At least 10 years of pharmacovigilance and end-to-end ICSR case-processing experience for the Manager level, or at least 12 years for the Associate Director level, with alternative thresholds for master’s or PharmD qualifications.
- At least 4 years of QPPV or deputy QPPV experience for the Manager level, or at least 6 years in a related function for the Associate Director level.
- Experience with safety data exchange, adverse-event reporting, pharmacovigilance agreements, quality systems, reconciliation, and CAPA processes.
- Advanced knowledge of global pharmacovigilance regulations, post-marketing surveillance, and regulatory reporting obligations.
- Experience with safety databases and supporting technologies, preferably Argus, plus project leadership and stakeholder-management skills.
Nice to have
- Master’s degree in chemistry, biology, or a related field.
- Doctor of Pharmacy degree.
Culture & Benefits
- Medical, dental, vision, and prescription coverage.
- Wellness resources, 401(k), and employee stock purchase plan.
- Paid time off, paid parental leave, and disability benefits.
- Remote work is available within the continental United States; local employees follow a hybrid schedule.
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