Associate Director, PV Case Operations (Pharmacovigilance)

157 200 - 256 600$

Формат работы

hybrid

Тип работы

fulltime

Грейд

director

Английский

Страна

Вакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:

TL;DR

Associate Director, PV Case Operations (Pharmacovigilance): Overseeing global pharmacovigilance case processing, ICSR quality, CAPA management, vendor performance, and regulatory compliance with an accent on inspection readiness, quality governance, and metrics-driven operations. Focus on leading root cause analysis, resolving audit and inspection findings, managing corrective actions, and ensuring timely delivery across clinical development and marketed products.

Location: Warren, NJ; Tarrytown, NY; or Cambridge, MA. The role requires 4 days per week on site and may involve 25% travel.

Salary: $157,200–$256,600 annually

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

Oversee accurate and timely pharmacovigilance case processing for global clinical development programs and marketed products.
Lead ICSR quality review, including narrative quality, case validity, assessment completeness, and source document reconciliation.
Establish quality review frameworks and sampling strategies based on case complexity, risk, and product lifecycle stage.
Analyze quality trends and operational metrics, identify root causes, and implement targeted improvements.
Lead RCA activities and own CAPAs through implementation, effectiveness checks, and closure.
Monitor vendor performance, contractual SLAs, regulatory timelines, inspection readiness, and communication with senior and external partners.

Requirements

Minimum bachelor's degree; an advanced degree is preferred.
10 years of pharmacovigilance, drug safety, or PV quality experience.
Previous experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.
Strong knowledge of FDA, EU, and ICH regulations and guidelines for clinical trial and post-marketing pharmacovigilance.
Experience managing and supervising teams on complex projects and working with cross-functional teams.
Ability to manage organizational projects, support staff, resolve issues, and escalate risks effectively.

Culture & Benefits

Science-driven work focused on developing medicines for patients with serious diseases.
Inclusive workplace and equal employment opportunity environment.
Benefits may include annual incentives, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
Onsite collaboration is emphasized for many roles.

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