The Product Safety Team (PST) lead for early oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the early oncology programs. The PST lead will also closely collaborate with a PK and toxicology leads to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first in human and phase I/II studies. The PST lead will be responsible and provide safety oversight (e.g. surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support all patient safety activities.
- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Responsible for safety surveillance for pharmaceutical / biological / drug –device combined early oncology products
- Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
- Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
- Independently write, review, and provide input on technical documents
- Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR’s, PADER’s and Safety sections of the IBs)
- Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
- Responsible for implementing risk management strategies for assigned product
- Proactively engaging, inspiring, coaching and mentoring team members and colleagues
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
- MD / DO with 2+ years of residency with patient management experience; Master Public Health is preferred in addition to MD / DO, not required
- 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
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