Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Support Safety Physicians with safety-related tasks across commercial products and products in clinical development.
Contribute to safety risk management including but not limited to routine review of safety data and pertinent scientific literature articles.
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment as directed by the Safety Physician.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.
Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases.
Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting.
Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. They were founded to develop a better way to treat the cellular drivers of tumor growth and committed to fair and equitable compensation practices.
Leads a team providing guidance on risk assessment methodologies.
Partner with tech-product-analytic teams to design and maintain sophisticated risk algorithms.
Develop a roadmap that defines the path to operationalize specific actions.
Aledade empowers independent primary care as the largest network in the country. They help practices, health centers, and clinics deliver better care to their patients and thrive in value-based care with a collaborative, inclusive, and remote-first culture.