Pharmacovigilance Specialist (home-based)

Overview:

NOTE: This role may be home-based from any location in the U.S.

The Pharmacovigilance (PV) Specialist is responsible for ensuring accurate collection, database entry, review, and reporting of clinical trial and post-marketing safety data. The PV Specialist may be required to assist senior staff in signal generation, safety analysis activities, and in the development and implementation of departmental processes and guidelines.

Responsibilities:

  • Perform safety review and analysis of adverse events for clinical and post-marketing products, including: triage, case review, narrative writing, coding, evaluation of listedness/expectedness, query generation, query tracking, and interface with reporters or investigators
  • Interface with medical reviewers and clients on adverse events and other safety-related issues
  • Participate in literature review activities related to adverse event reporting
  • Generate necessary safety reports with minimal supervision
  • Assist with preparation of safety reports (e.g. Periodic Reports and Periodic Safety Update Reports, and interface with safety writer as needed
  • Assist with preparation of Risk Management documentation and activities
  • Assist with Case Report Form (CRF) review as requested, assessing data provided on CRFs to ensure medical safety and compliance, and generating queries

Qualifications:

  • Position requires a Bachelor's degree, preferably in a medical/scientific field (eg., BSN or R.Ph.), plus 2 years of relevant PV/Clinical experience.
  • Must possess good clinical interpretation skills based on limited information, a strong understanding of medical terminology, and knowledge of FDA and ICH regulations.
  • Understanding coding standards using MedDRA or other coding dictionaries is beneficial, as is drug safety database knowledge.
  • Strong oral and written communication skills and the ability to work independently or with minimal guidance is essential.

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