Directs and oversees on a daily basis the clinical trials and post-marketing adverse event processes involving the collection, data entry, presentation of data for medical evaluation, reporting, and follow-up in accordance with the ICH/FDA/EU guidelines and Taiho SOPs.
Maintains and directs the Pharmacovigilance Operation team daily communication and collaboration with all functional groups involved in the management of the pharmacovigilance process including other departments at TOI, Taiho affiliates or partners , and external data management/regulatory/clinical vendors .
Oversees punctuality and timeliness in the collection, processing, and regulatory reporting of safety reports.
Ensures the accurate and consistent coding of adverse event data into the Global Safety Database.
Oversees and directs SAE reconciliation processes on a continuing basis and provides a written summary of all adverse events on a routine basis as part of the monthly drug safety reporting process.
Chair internal and external safety committees meetings as needed.
Maintains the oversight of global reporting requirements in all countries involved in the development and commercial programs and ensures the correct reporting requirements are registered in ARISg.
Participates in the preparation and review of documents for submission to regulatory authorities including annual and periodic safety reports and similar submissions for other worldwide regulatory authorities.
Presents Pharmacovigilance-related training at investigator meetings and other internal and external meetings as required.
Supervises and conducts Pharmacovigilance training for clinical monitors, third party CROs, sales representatives, Medical Science Liaisons and other staff members as required.
Evaluates and reports to management new and recurrent safety concerns. Monitors trends in the safety of the TOI development and post-marketing programs.
Ensures that the functional organization of Pharmacovigilance, the adverse event process, SOPs and all related adverse event documentation are in a continuing state of readiness for external audits.
Establishes processes and ensures that SAE reconciliation plan documents and Adverse Event Reporting Plan documents are accurately documented.
Ensures that SAE report specifications, AE and SAE forms, and other Pharmacovigilance-related functionalities in eCRF are created per approved specifications.
Reviews and provides input for Safety-related sections of new or amended protocols , CRF design, Informed Consent, Investigator's Brochure, NDA/MAA submissions, Risk Management Plans, PSMF, labeling documents and other Safety-related documents.
Provides assistance with a multitude of other tasks as required in support of the TOI clinical development and post-marketing programs.
Reviews and negotiates contracts and budgets provided by third party vendors.
Reviews ARISg Data Entry Specifications and other ARISg and Business Objects related manual or instructions for the Pharmacovigilance Operations team to be able to perform needed activities accurately and more efficiently.
Supervisory responsibilities as assigned.
This position may require some travel.