Services
Interim Head of PV
Able to act as interim Head of PV for early stage biotech companies when ramping up for Phase 3 and regulatory submission. Streamlining out-sourced PV services, design and recruitment of in-house PV staff, establishing PV quality system and governance structure.
Expert Medical Safety Review
Medical review of individual and aggregate safety reports (IB, CCDS, Study Protocols, PADER, PSUR, CSRs). Deep dive review of regulatory submission documents (M2.5 Clinical Overview, M2.7.4 Summary of Clinical Safety/Integrated Summary Safety, EU-RMP, Core Labels (USPI, SmPC). Primary contact for regulatory queries and regulatory meetings (FDA Ad Comm preparation).
PV Vendor and Partner Oversight
Establishing and continued oversight of PV vendor(s) and business partners. Coordination of end to end processes between clinical trial CRO, GSD vendor, other PV services (e.g. literature) and business partners.
PV System and Inspection Readiness
Close collaboration with the quality function to ensure adequacy of PV quality system (SOPs, training, CAPA management), and inspection readiness (systematic internal audit program, preparation of story boards, mock inspections)
Support For Korea-based Companies
With proficiency in Korean, able to communicate and collaborate with Korea-based pharmaceutical and biotech companies. Able to US and global pharmacovigilance expertise and advice to companies looking to establish or expand US operations.
Contact
Let's discuss how I can meet your company's needs over a free 30-min Introductory Consultation.