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Sr Medical Director, Product Safety Lead
Location:
North Chicago, IL
Description:
Description: 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, 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. PSURs,DSURs, PADERs 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 Significant Work ActivitiesContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredFrequent to continuous computer usage (greater or equal to 50% of the workday) is requiredQualifications 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 Ability to lead cross-functional team in a collaborative environment Evaluate and make independent decisions Effectively present recommendations / opinions in group environment both internally and externally
Company:
Capabilix
Posted:
May 17 on Manatal ATS
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More About this Listing: Sr Medical Director, Product Safety Lead
Sr Medical Director, Product Safety Lead is a Executive Director Job at Capabilix located in North Chicago IL. Find other listings like Sr Medical Director, Product Safety Lead by searching Oodle for Executive Director Jobs.
Sr Medical Director, Product Safety Lead is a Executive Director Job at Capabilix located in North Chicago IL. Find other listings like Sr Medical Director, Product Safety Lead by searching Oodle for Executive Director Jobs.