3 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 GPS International PV structure with an accent on global regulatory compliance, responsible-person and vendor oversight, and pharmacovigilance agreements. Focus on researching regulatory requirements, maintaining Argus Global Safety Database configuration compliance, supporting geographic expansion, and developing SOPs and work instructions.
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.
What you will do
- Support the build-out and management of the GPS International Pharmacovigilance structure.
- Help ensure GPS procedures comply with global pharmacovigilance regulations and support regulatory troubleshooting.
- Oversee local Responsible Persons for Pharmacovigilance and key vendors.
- Review regulatory intelligence, research pharmacovigilance regulations, and develop related agreements and contracts.
- Act as a liaison for Argus Global Safety Database configuration compliance during geographic expansion initiatives.
- Author and review SOPs and work instructions, present safety initiatives, and provide pharmacovigilance guidance to cross-functional teams.
Requirements
- Bachelor of Science degree or equivalent 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 independently, manage multiple priorities, and operate effectively in a matrix environment.
- Strong written and verbal communication, attention to detail, and collaboration skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Work location must align with the United States-based role and selected Boston flex arrangement.
Culture & Benefits
- Inclusive benefits covering medical, dental, and vision care.
- Generous paid time off, including company shutdowns in summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy, matching charitable donations, and 401(k).
- Flexible remote, hybrid, and on-site work options subject to company policy.
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