Associate Director, Pharmacovigilance Operations

US-NJ-Princeton
Category
Pharmacovigilance
Travel
10%
Type
Regular Full-Time

Position Summary

This position has global responsibilities for a wide variety of Pharmacovigilance activities for all drug development and post-marketing programs at Taiho Oncology, Inc., (TOI), and Taiho Pharma Europe Ltd. (TPEL). Responsibilities include the direction and oversight of all stages of adverse event processing, tracking, review, evaluation, reconciliation, and reporting in cooperation with the global Taiho Pharmacovigilance Organization and third party CROs involved in remote/outsourced activities. Responsibilities also include management of several aspects of TOI's and TPEL Pharmacovigilance program.

Responsibilities

Responsibilities and Duties:

  • 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.

Qualifications

Educational Requirements:  

  • Bachelor's degree or higher in a health related discipline, or equivalent experience. An RN, R.Ph., or Pharm D. degree is preferable.

Experience:

  • Experience in the adverse event and aggregate reporting processes.
  • 5-7 years’ experience in Pharmacovigilance environment with experience in managing adverse event and SAE processing on a global basis.
  • Operational direction and management experience.
  • Experience in different pharmacovigilance activities with a strong working knowledge of the ICH/FDA/EU guidelines for GCP and Clinical Safety Reporting on a global basis.

Other Skills and Abilities:

  • Strong working knowledge of ICH/FDA guidelines for GCP and Clinical and post­ marketing Safety Reporting on a global basis.
  • Highly developed skills in verbal and written communication, planning, organizational, and a good working knowledge of the clinical study and/or post-marketing setting.
  • Working knowledge of drug development process.
  • Ability to multi-task.
  • Attention to detail with a highly consistent focus on quality.
  • Excellence in written and oral communication.
  • Ability to supervise people.

Language Skills:

  • Ability to read, analyze and interpret professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedures.
  • Ability to effectively present information and respond to questions from internal and external clients.

Mathematical Skills:

  • Ability to work with mathematical concepts such as probability and statistical inference.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.

Computer Skills:

  • Experience with the use of global safety databases is required.
  • Experience with Pharmacovigilance management tracking tools.
  • Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).

 

 

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