Senior Director, Drug Safety and Pharmacovigilance

Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data. Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data. In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications. Support the clinical development team in the review of key documents, including protocol and ICFs. Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting. Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities.