Coordinator, Pharmacovigilance Operations

US-NJ-Princeton
Category
Pharmacovigilance
Type
Regular Full-Time

Position Summary

This position has 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 adverse event data entry, tracking, report generation and submission, records management as well as other project-related tasks in cooperation with the Global Taiho Pharmacovigilance Organization and third party CROs involved in remote/outsourced activities.

Responsibilities

  • Monitors adverse events receipt, enters data in the tracking system and the safety database, and generates reports for distribution and submission in accordance with the ICH/FDA guidelines and Taiho SOPs.
  • Ensures compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreement (SDEA) with business partners.
  • Tracks expedited submission history in the safety database and generates regulatory compliance reports.
  • Prepares Investigators letters for reportable cases for distribution to investigational sites.
  • Generates or assist in the generation of Analysis of Similar Events (AOSE) letters including performing database search.
  • Prepares or assists in the preparation of periodic reports as well as other reports for both external and internal use from the safety database.
  • Maintains daily communication and collaboration with all functional groups involved in the management of the Pharmacovigilance process including Taiho Japan, the CRO and TOI Pharmacovigilance MDs, the TOI medical monitors and external data management vendors.
  • Maintain the departmental electronic and hard copy filing for cases as well as other PV documents in a continued state of readiness for external audits. Provides assistance with a multitude of other tasks as required in support of the TOI clinical development program.
  • Takes meeting minutes as needed.

Qualifications

Educational Requirements:  

  • Associate degree in a health related field is preferred, but not required.

 

Experience:

  • At least 1 year of experience in data entry in any safety database in a pharmaceutical company.

 

Other Skills and Abilities:

  • Attention to detail with a highly consistent focus on quality.
  • Familiarity with medical terms and concepts.
  • Verbal and written communication skills, planning, organizational, and a good working knowledge of the clinical study setting are preferable.
  • Ability to multi-task a wide variety of activities in a fast-paced environment.
  • Experience with Pharmacovigilance management tracking tools.
  • Excellence in written and oral communication.
  • Positive can-do attitude with the ability to work well with peers and with all levels of management.

 

Language Skills:

  • Ability to read and comprehend instructions, short correspondence, and memos.
  • Ability to write basic correspondence.

 

Mathematical Skills:

  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, and percent and to draw and interpret graphs.

 

Reasoning Ability:

  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  • Ability to deal with problems involving several concrete variables in standardized situations.

 

Computer Skills:

  • Highly developed computer skills including entering safety data in safety databases is required.
  • Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).

 

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk, reach with hands arms and stoop, kneel, crouch, or crawl.
  • The employee must occasionally lift and/or move up to 10 pounds.
  • Specific vision abilities required by this job include close vision and ability to adjust focus.

 

Work Environment:

  • The noise level in the work environment is usually quiet.

 

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

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