Position Summary:
Join Deciphera Pharmaceuticals as an Associate Director, Pharmacovigilance Operations. Lead and oversee adverse event case management, support study teams, maintain the drug safety database, and collaborate on risk management for clinical trials and post-marketing. Report to the Director, Pharmacovigilance Operations.Key Responsibilities:Oversee vendor case processing and compliance.Establish and monitor CRO/vendor KPIs.Support the oversight and management of global safety data exchange agreements.Develop and maintain safety documents including Safety Management Plans, SOPs etc.Collaborate with other departments such as Regulatory Affairs, Quality Assurance, Clinical operations, Data management etc.Maintain knowledge and compliance to current regulatory safety reporting guidelinesParticipate in audits and regulatory inspections.Provide technical support entering and retrieving information from the safety database.Support budget planning and trend analysis.Assist in implementation and management of GVP/GCP quality programs.Manages, assist and/or conduct external site and vendor audits.Provide input on GVP Corrective and Preventive Action plans.Train employees on safety reporting responsibilities.
