Senior Drug Safety Operations Manager

Senior Drug Safety Operations Manager

Requirements

• BS/BA degree in related discipline and a minimum of 9 years of related experience; or MS/MA degree in related discipline and a minimum of 7 years of related experience; or PhD in related discipline and a minimum of 2 years of related experience; or equivalent combination of education and experience.
• May require certification in assigned area.
• Knowledge of biotechnology/pharmaceutical sector practices.
• Wide knowledge of relevant regulations and guidance governing patient safety.
• Demonstrates skill and insight in gathering, sorting and applying key information to solve problems.
• Demonstrates an understanding of organizational and planning capabilities by managing own time to complete assigned work.
• Demonstrates clear and effective verbal and written communication.
• Good interpersonal skills and emerging ability to bring differing views to develop an agreed upon resolution.
• Applies strong analytical and business communication skills.

Responsibilities

• Process and assess SAEs and AEs from receipt at Exelixis to case closure in the Argus database, including query generation, MedDRA coding and narrative writing.
• Manage, define, and apply a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
• Train new safety staff on Argus and case processing.
• Collaborate with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
• Perform Safety Study Lead activities including Review of, Investigator Brochures, study protocols and participation in IND Annual Reports in support of the Drug Safety Physician.
• Development of study-specific and program-level safety management plan from CRO or Exelixis GPS template.
• Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF).
• Monitor activities of CRO’s and partners to ensure adherence and compliance with applicable SMPs, PVAs, and other contractual agreements involved in study lead activities.
• In collaboration with Data Management, perform SAE reconciliation activities per study level plans.
• Develop and/or update SOPs, processes and practices for study lead and SAE case processing activities in accordance with drug safety and pharmacovigilance regulations and standards.
• Lead self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Additional duties and responsibilities as required.

Preferred Qualifications

• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.