The Product Safety Team (PST) lead for late stage 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 oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.
Responsibilities:
- 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 products
- Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
- Effectively write, review and provide input on technical documents independently
- Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
- Responsible for implementing risk management strategies for assigned products
- Proactively engaging, inspiring, coaching and mentoring team and colleagues
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
- Strong team player, able to adapt and work in a fast pace environment
- Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)