Provide pharmacovigilance and drug safety leadership and input for the Company’s clinical development and postmarketing programs, including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs while collaborating with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), and other internal and external entitles to contribute to overall program execution while ensuring safety strategy, quality compliance and operational excellence. · Oversee the preparation of pre- and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and Six-Month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports, ensuring safety profile/topics across various regulatory safety documents for the Company’s assigned products.