4 дня назад
International PV Senior Specialist (Pharmacovigilance)
102 600 - 153 800$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
International PV Senior Specialist (Pharmacovigilance): Supporting the build-out and management of the global International PV structure with an accent on regulatory compliance, pharmacovigilance intelligence, vendor oversight, and geographic expansion. Focus on researching global PV regulations, configuring the Argus Global Safety Database, developing SOPs and agreements, and solving cross-functional compliance challenges.
Location: Boston, MA, United States. Remote-eligible with a choice of remote work five days per week with occasional office visits, hybrid work remotely up to two days per week, or on-site work five days per week.
Salary: $102,600–$153,800 per year, plus potential annual bonus and equity awards.
Company
Vertex is a global biotechnology company focused on scientific innovation and patient outcomes.
What you will do
- Support the build-out, management, and continuous improvement of the GPS International Pharmacovigilance structure.
- Help ensure procedures comply with global pharmacovigilance regulations and support oversight of local Responsible Persons for Pharmacovigilance and key vendors.
- Review, assess, and track global pharmacovigilance regulatory intelligence and research applicable regulations and guidelines.
- Develop and review pharmacovigilance agreements, contracts, standard operating procedures, and work instructions.
- Act as a business liaison for Argus Global Safety Database configuration compliance during pharmacovigilance intelligence and geographic expansion initiatives.
- Present safety issues and initiatives, respond to cross-functional and vendor questions, and provide pharmacovigilance guidance across global teams.
Requirements
- B.S. or equivalent degree with 3–4 years of relevant experience, or PharmD, M.S.N., or equivalent degree with 3–5 years of relevant experience.
- Current understanding of global pharmacovigilance regulatory requirements.
- Ability to work autonomously in a matrix environment, manage multiple priorities, and collaborate cross-functionally.
- Strong written and oral communication skills with close attention to detail.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
Culture & Benefits
- Continuous learning and encouragement to adopt advances in AI, technology, automation, and industry trends.
- Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy, matching charitable donations, and 401(k).
- Flexible work designation with remote, hybrid, and on-site options.
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