Pharmacovigilance Operations Manager

6 days ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
About the Role

Deciphera Pharmaceuticals is seeking a highly skilled Pharmacovigilance Operations Manager to join our team. As a key member of our Pharmacovigilance department, you will be responsible for providing direction and oversight to ensure the efficient and compliant management of adverse event cases.

Main Responsibilities

  • Lead the coordination of day-to-day operational ICSR activities, including review of incoming adverse events to determine required action.
  • Provide oversight and review of vendor case processing and submission activities, ensuring compliance through monitoring reports and other oversight activities.
  • Manage vendor personnel, including training and development of self-sufficiency.
  • Ensure all safety reports received from clinical trials are processed in a consistent and compliant manner.
  • Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.

Requirements

  • Bachelor's or Advanced degree in a life science, nursing, pharmacy, or healthcare-related profession.
  • 6+ years of direct pharmacovigilance experience in the pharmaceutical industry.
  • Experience with Argus Safety database and a solid understanding of US and ex-US pharmacovigilance regulatory requirements.
  • Excellent analytical, verbal, and written communication skills.

About Deciphera Pharmaceuticals

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve lives of people with cancer. We have a diverse pipeline of drug candidates, and our team is passionate about making a difference.



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