Posted on April 15, 2020
In progressLooking for an active member of the team to conduct the following tasks. Role is expected to be part time- 10 to 15 hours per week, can be remote.
PV vendor oversight
· Establish relationship with Syneos and provide ongoing oversight via regularly scheduled meeting
· Review of project specific documents
· Ensure Syneos is delivering on tasks as defined in the SOW
· Miscellaneous safety operations related tasks as assigned
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 Syneos
PV Strategy
· Participate in study execution team (SET) meetings
· Participate in other study related meetings as needed
· 1:1 meeting with Alladapt personnel
· Provide PV strategic advice to Alladapt
Inspection readiness
· Review Syneos SOPs as needed and supplement SOPs requisite to support the PV system
· Ensure oversight of Syneos is documented
· Contribute to Syneos expedited reporting plan for IND and investigator submissions
· Ensure internal safety reviews and any actions taken are documented
not in scope:
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
o Write/update SOPs to include PM sources of AEs and processes specific to PM cases
o Work with QA to qualify vendors who have the potential to learn of AEs (patient advocacy vendors, patient support programs, specialty pharmacies, market research)
o Write pharmacovigilance agreements (PVAs) and train these vendors
o Develop a plan to write the Periodic Adverse Experience Report (PADER) which is due to FDA every 3 months after approval