This role will include support for development of the safety/PV department, support and management of internal and external PV stakeholders, development and oversight of PV CRO functions and compliance for the SMP (safety management plan), adverse event case management, aggregate report development and submissions, SOP, WI’s, document guidance and form development, support of the signal detection/risk management of safety data for clinical trials and post marketing (where applicable), CAPA and quality oversight, support of audits and inspections and partner management (when applicable). The base pay range for this position at commencement of employment is expected to be between $210,000 to $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.