Associate Director, PV Sciences, Global Medical Safety Oncology - Boston
2 weeks ago
Job summary
The Associate Director of PV Sciences will support the Global Safety Lead for assigned oncology pharmaceutical/biological/drug-device combined products.Responsibilities include safety surveillance, signal detection, risk management activities.
This role requires in-depth knowledge of local and global health authority requirements,
a highly effective global safety organization in full compliance worldwide regulations,
and ability to maintain up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure,
as well as other labeling documents.
- Analyze and interpret safety data from various sources including non-clinical clinical post-marketing scientific literature.
- Facilitate ongoing safety surveillance for assigned products assisting with or leading data collection assessment for GPSE Safety Team GST
- Liaise with colleagues relevant functional areas within outside PSPV gather provide input appropriate sections critical documents e.g protocols amendments ICFs IBs core data sheets IMPDs CSRs INDs NDAs BLAs CTAs
Job description
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