Remote PV Operations Specialist

Summary

Join Pyros as a PV Operations Specialist to assist in the overall quality and compliance of PV operations, including global literature surveillance, adverse event case processing, and submission of individual case safety reports.

Requirements

• Experience with end-to-end ICSR and aggregate report processing, including ICSR processing within Oracle Argus Safety of spontaneous, solicited (e.g. – specialty pharmacy), and literature cases
• Perform oversight of follow-up queries
• AE case intake, triage (including duplicate case checks), processing, and assessment (e.g. – event listedness, event seriousness, etc.)
• Experience in PV Operations; either in a Pharmaceutical or CRO environment
• Knowledge of best practices for PV and compliance with FDA and global regulatory agencies
• Experience in working with a PV Operations group to facilitate on-time case processing and assisting in implementing remedial actions, if needed
• Mentoring others in PV Operations
• Compilation of meeting minutes, metrics, and SLAs
• Collaborating with multiple PV vendors/suppliers to ensure contractual and regulatory authority PV obligations are met
• Understanding of the nuances of complicated patient histories (e.g. - concomitant medications) and comorbid disease states on the therapeutic outcome of the patient
• Postmarketing experience is preferred
• ICSR submission experience to FDA is preferred
• Call center AE and SS intake and/or follow-up is preferred
• Veeva Vault Safety database experience is preferred

Responsibilities

• Ensure PV compliance with global regulatory and competent health authority requirements by oversight of all case processing activities
• Perform prospective QC of cases and ensure metrics and service level agreements (SLAs) are met per safety data exchange agreement (SDEA) contracts
• Reconcile ICSRs with omnichannel intake methods and manage ICSR triage and workflow routing
• Support risk benefit analysis, aggregate reporting, and signal detection by performing QC of queries from the global safety database
• Assist in documenting literature surveillance and triaging of pertinent medical literature associated with risk benefit analysis of all Pyros products
• Assist in operational support and meeting minutes for the Drug Safety Review Board (DSRB)
• Understand and assist in implementation of best practices for coding of AE terms to MedDRA and the impact of MedDRA upgrades
• Review and/or writing of work instructions, conventions, and SOPs as needed
• Assist in computer systems validation (CSV) for upgrades/changes to the global safety database, including user acceptance testing (UAT)
• Possible call intake and outbound follow-up attempts with postmarketing reporters
• Preparing for audit and inspection readiness
• Maintain proficiency in global drug safety regulations as it pertains to Pyros products
• Support the growth of an in-house PV Operations Team

Benefits

• Competitive salary and benefits package
• Medical, dental, vision (most tiers are fully compensated by Pyros)
• HSA and FSA
• Life and supplemental life insurance
• 401(k) with company match
• Generous PTO with rollover
• Generous holidays