Advanced Clinical

Pharmacovigilance Specialist (home-based)

US-Nationwide
Req No.
2017-7396
Type
Regular Full-Time

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
  • For drugs, ensure compliance with FDA/international drug safety regulations, client and/or Advanced Clinical standard operating procedures (SOPs) in all aspects of data processing and reporting of SAEs from clinical trials and other studies, and spontaneously reported SAEs and non-serious adverse events (NSAEs) for marketed products.
  • For devices, ensure compliance with FDA/international device safety regulations, client and/or Advanced Clinical standard operating procedures (SOPs) in all aspects of data processing and reporting of safety data, particularly for unanticipated adverse device effects (UADEs) from clinical trials performed under an investigational device exemption and medical device report (MDR) reportable adverse events for marketed devices. 
  • Analyze subject medical records and write SAE/UADE and case summaries.
  • Preparation of MW 3500A or CIOMS equivalent for any expedited SAE.
  • 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
  • Assist with the review, development, and implementation of MedDRA coding convention and other safety-related documents, such as study protocols, safety data collection forms and templates, case report forms, Investigator Brochures, etc.
  • Be available for some flexible shifts and on-call when needed.

Qualifications

Education:

5+ years of Pharmacovigilance experience with an RN credentials or above; or equivalent working Pharmacovigilance experience with degree less than RN, such as Bachelor’s degree in healthcare, pharmacy, life science.

 

Experience:

Minimum two years of drug safety/pharmacovigilance experience and experience writing narratives and critical medical review of AEs/SAEs, previous case processing experience in clinical trials, and previous ARISg or Argus experience

 

Other:

  • Strong organizational skills; good oral and written communication skills and the ability to articulate issues.
  • Ability to assume a high level of responsibility, ensuring proper reporting of adverse events within the timelines mandated by internal regulatory and client guidelines.
  • Ability to maintain confidentiality.
  • Training Knowledge of Good Clinical Practices (GCPs), FDA and EMA regulations, ICH guidelines, global adverse event (SAE/NSAE) reporting requirements and reporting procedures for clinical trials and marketed products.

 

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