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Dragonfly Therapeutics seeks a Director/Sr. Director/Executive Director of Pharmacovigilence & Drug Safety to support product safety and compliance. The successful candidate will report to the VP of Pharmacoviglence and be responsible for managing drug safety data to support signal detection and risk/benefit profile evaluation, author safety documents, perform QC of safety documents, organize cross-functional Safety Management Team meetings and collaborate with colleagues in Clinical Development, Clinical Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, and non-clinical safety departments, as well as provide vendor oversight to CROs. The successful candidate will oversee the ICSR data quality from safety vendors and ensure compliance with all applicable US and foreign legal and regulatory requirements to ensure compliance with global drug safety regulations while working in a highly collaborative work environment with a multi-disciplinary and diverse team, focusing on multiple programs in parallel.
Responsibilities:
Collaborate, and oversee the work of CROs directly involved in ICSR management, aggregate & periodic reporting, and business partner reporting.
Support signal detection and risk management activities
Support Development activities as a member of CTT
Other activities
Qualifications:
Full Time
Scientific Services
$107k-141k (estimate)
03/13/2024
05/12/2024
dragonflytx.com
CAMBRIDGE, MA
100 - 200
2015
BILL HANEY
<$5M
Scientific Services