Purpose:
Responsible for supporting the Product Safety Lead (PST) in overseeing the comprehensive safety surveillance of one or more neuroscience products throughout their lifecycle, including signal management, interpretation of pharmacovigilance regulations, and supporting all safety deliverables.
Responsibilities:
- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Safety surveillance for pharmaceutical / biological / drug –device combination neuroscience products
- Contribute to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, periodic safety reports, regulatory responses and risk management plans
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to crossfunctional teams
- Oversight of safety surveillance and pharmacovigilance activities for neuroscience products in clinical trials and post marketing setting
- As the PST Lead write, review and provide input on technical documen