Pharmacovigilance Operations Manager
6 days ago
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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