Senior Medical Director

US-WA-Seattle
Job ID
2017-1019
Category
Clinical & Medical Affairs

Overview

Dendreon is looking for a Senior Medical Director (Pharmacovigilance) with 5+ years pharmaceutical/safety experience and PV management experience. This position ensures that safety practices are supported globally.

 

This position 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 also serves as a lead on global committees and task forces to ensure the alignment of safety processes across the sites are in compliance with appropriate regulations.

 

The director interacts with senior leaders of other functions including clinical, regulatory, data management and quality, as well as external vendors. This person works independently with limited supervision, and makes decisions based on a thorough understanding of Dendreon’s products and processes.

 

Minimal travel <10%.

Responsibilities

  • Advise Executives on PV strategic matters.
  • Prepare risk management plans and implement programs.
  • Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s).
  • 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 international/domestic regulatory inspections.
  • Expert in any PV Compliance activity.
  • Manage direct reports globally.
  • Oversee PV contract operations.

Qualifications

  • MD strongly preferred.
  • 5 + years of pharmaceutical/safety experience and PV management experience.
  • Proficiency in MS Office Suite.
  • Experience as a lead on global committees.
  • Be able to meet the minimal travel requirement (<10%).

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