The Indication Product Safety Team (PST) lead for immunology products, under the direction of the Asset PST Lead will be actively and closely collaborating with the development medical lead, setting the safety strategy for a product in a development or approved indication. Indication PST lead will be responsible to one or more indications and will support safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, etc…) together with the other members of the safety team (safety scientists, safety architects, and other cross functional colleagues). The PST lead will also closely collaborate with statistical science, epidemiology, regulatory and clinical development leads as well as medical affairs colleagues to support the asset strategy in the given indication with patient safety expertise.

Indication 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, PSURs, and IB updates.

Responsibilities

• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
• 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
• Understanding of the relevant to the patient safety evaluations pharmacology, and non-clinical toxicology data
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Strong team player, able to adapt and work in a fast-paced environment
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
• 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
• Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)