Director, Patient Safety ICSR (Biotech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Director, Patient Safety ICSR (Biotech): Overseeing global ICSR processing and managing external PV partners with an accent on drug-device combination products and regulatory compliance. Focus on implementing safety database configurations, developing innovative best practices, and ensuring inspection-ready operations worldwide.
Location: Boston, MA. Must be based in the US (Remote-Eligible: candidates can choose between Remote, Hybrid, or On-Site).
Salary: $196,200 - $294,400
Company
Vertex is a global biotechnology company that invests in scientific innovation.
What you will do
- Oversee global ICSR processing and manage external PV partners and vendors.
- Establish and implement processes for drug-device combination product quality complaint triage and adverse event reporting.
- Lead and mentor staff in all aspects of pre- and post-market pharmacovigilance.
- Develop standardized practices, procedures, metrics, and KPIs for Global Patient Safety.
- Contribute to the implementation of Global Safety Database configurations for drug-device combination products.
- Represent GPS in cross-functional initiatives and ensure operations are compliant and inspection-ready.
Requirements
- B.S. in life sciences or allied health professional degree.
- 10+ years of direct pre- and post-marketing PV experience.
- 5+ years of direct external partner and vendor/outsourcing management experience.
- US work authorization required (E-Verify employer).
- Strong technical PV expertise and project management skills.
- Ability to manage complex regulatory requirements for drug-device combination products.
Culture & Benefits
- Flexible work arrangements: choose from Remote, Hybrid, or On-Site designations.
- Competitive compensation including an annual bonus and annual equity awards.
- Comprehensive medical, dental, and vision benefits.
- Generous paid time off, including a week-long company shutdown in Summer and Winter.
- Financial perks including a 401(k) plan and a generous commuting subsidy.
- Educational assistance programs, including student loan repayment.
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