General Summary:
International Pharmacovigilance (PV) Specialist supports management of the GPS International PV structure, troubleshooting issues and improving internal procedures to ensure compliance with applicable regulatory requirements.
Key Duties and Responsibilities:
- Ensure GPS procedures are compliant with global PV regulations
- Contribute to vendor oversight activities; support oversight of local Qualified Persons for Pharmacovigilance (QPPVs)
- Research PV regulations/guidelines; review/assess/track global PV regulatory intelligence
- Review PV agreements supporting local/regional PV requirements
- Plan/verify safety database configuration compliance based on PV intelligence and geographic expansion
- Perform compliance impact assessments as assigned
- Assist with safety-related presentations; represent GPS/Vertex regarding patient safety as assigned
- Respond to cross-functional team and vendor questions; provide PV information/guidance
- Collect/analyze PV data and feedback; triage/escalate patient safety matters
- Liaise and coordinate with international teams; promote GPS activities, policies, and best practices
Knowledge and Skills:
- Matrix environment effectiveness; multitask with attention to detail
- Solid written/verbal communication; work with moderate supervision and in teams
- Adapt to changing priorities; understand established procedures
- Basic understanding of global PV regulatory requirements
- Proficient in Microsoft Office (Word, Excel, PowerPoint)
Education and Experience:
- Bachelorβs degree (or equivalent)
- Typically 1β3 years relevant work experience
Work Arrangement:
- Remote-Eligible (Remote / Hybrid / On-Site options)