Senior Medical Director

Purpose:

The Product Safety Team (PST) lead for Immunology products, under the direction of the Group Lead and TA Head will ensure safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance and supporting all patient safety activities.

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 Immunology 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
• 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