International PV Senior Specialist
$102.6k - $153.8kVertex Pharmaceuticals
Vertex Pharmaceuticals seeks an International PV Senior Specialist to build and manage global pharmacovigilance structures, ensuring regulatory compliance across regions. The role involves overseeing local compliance, managing vendor relationships, and supporting geographic expansion initiatives with substantial autonomy.
Responsibilities
- Ensure GPS procedures comply with global pharmacovigilance regulations and standards
- Oversee local Responsible Persons for Pharmacovigilance and key vendor performance
- Review and track global pharmacovigilance regulatory intelligence and research requirements
- Develop and review pharmacovigilance agreements and contracts supporting regional needs
- Author and review Standard Operating Procedures and Work Instructions with management support
Requirements
- Bachelor's degree and 3-4 years relevant experience, or advanced degree (PharmD/MSN) with 3-5 years experience
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
- Knowledge of global pharmacovigilance regulatory requirements and guidelines
- Strong written and oral communication skills with attention to detail
- Ability to work autonomously in matrix environments and manage multiple priorities
- Experience with pharmacovigilance procedures, agreements, and compliance documentation
Compensation: $102,600 - $153,800
Vacancy posted 23 days ago
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