Project Closed

Drug Safety Expert for Phase 2 Immunology Trial and Beyond

Small, CA based, phase 2 immunology drug sponsor in need of drug safety expertise:

  • Enhanced Pharmacovigilance Plans and REMS programs
  • Signal detection programs and Global Safety Board processes
  • PV Operations support
  • Vendor management support
  • Executing the RFP process for PV and Medical Information vendors
  • PSMF support
  • PV agreement support
  • QC of ICSRs

Among other recommendations and actions, it will be essential to establish a Pharmacovigilance (PV) System that can support the lifecycle of our Phase 2 trial and possibly others. The immediate tasks will focus on a single Phase 1/2 study of approximately 72 patients that will be conducted in the US only. The safety database will be held by the external CRO vendor for the duration of the study. During the development phase, it is critical to ensure the quality of AE/SAE and other safety parameters is good so that the benefit-risk profile of can be established. Additional task- develop the PV system during the early clinical development phase; additional SOWs will be put in place as appropriate to later clinical development states, pre-approval phase and post-approval phase. Oversight of the pharmacovigilance aspects of the external CRO vendor.

Project Scope

PV vendor oversight
  • Establish relationship with Syneos and provide ongoing oversight via regularly scheduled meeting
  • Review of project specific documents
  • Miscellaneous safety operations related tasks as assigned
  • Vendor management support
Manage Signal Detection/Safety Assessment Program
  • Review current safety plan
  • Contribute to the IDMC (Independent Data Monitoring Committee) charter and TLFs
  • Develop core safety information in concert with Clinical Development
  • Lead Safety Management Activities for Internal Team in concert with CRO
PV Strategy
  • Participate in study execution team (SET) meetings
  • Participate in other study related meetings as needed
  • 1:1 meeting with clinical personnel
  • Provide PV strategic advice
Inspection readiness
  • Review CRO SOPs as needed and supplement SOPs requisite to support the PV system
  • Ensure oversight of CRO is documented
  • Contribute to CRO expedited reporting plan for IND and investigator submissions
  • Ensure internal safety reviews and any actions taken are documented


The anticipated charges will be: approximately 10 hours per week; with the cap at 15 hours/per week per month for two years.

  • Exclusions
FDA Submission
  • Assess if REMS will be needed to support submission and if so, develop strategy
  • Contribute to writing and/or reviewing Module 2 documents and the safety sections of the USPI
Launch readiness
  • Ensuring that the PV system is ready for post-marketing (PM) cases
    • Write/update SOPs to include PM sources of AEs and processes specific to PM cases
    • Work with QA to qualify vendors who have the potential to learn of AEs (patient advocacy vendors, patient support programs, specialty pharmacies, market research)
    • Write pharmacovigilance agreements (PVAs) and train these vendors
    • Develop a plan to write the Periodic Adverse Experience Report (PADER) which is due to FDA every 3 months after approval