Director, Pharmacovigilance

Job Locations US-WA-Seattle
Job ID
2018-1110
Category
Regulatory Affairs

Overview

The Director Pharmacovigilance is responsible for managing all of the PV operations/ activities associated with collecting, processing, and reporting spontaneous adverse drug reactions for Dendreon’s marketed products and serious adverse events from clinical trials. This position interacts with senior leaders of other functions including clinical, regulatory, data management and quality, as well as external vendors. This position works independently with limited supervision, and makes decisions based on a thorough understanding of Dendreon’s products and processes. This position ensures that safety practices.


 

Responsibilities

  • Advise Executives on PV strategic matters.
  • Responsible for the oversight of signal detection and risk management activities for designated product.
  • Ensures periodic reports are prepared and submitted to regulatory authorities as required.
  • Support developmental programs, including both early and late stage development as required.
  • Assist with regulatory inspections.
  • Experienced in PV Compliance activity.
  • Oversee PV contract operations.

 

Qualifications

  • Degree in nursing, pharmacy or healthcare-related field.
  • 5 years of pharmaceutical/safety experience.
  • The ability to travel when necessary.

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