Sr Drug Safety Operations Manager

SUMMARY/JOB PURPOSE:

This role is responsible to assist with overseeing all aspects of drug safety study operational activities from study start up to close out. This role assists with oversight of clinical trial safety operational vendor activities and supports all major tasks related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and PV regulations and Global Patient Safety (GPS) department procedures in all aspects of drug safety case processing and reporting.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Technical duties include but are not limited to:

• 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.

• 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.

• 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. Leads cross-functional projects, obtains input, and gains consensus where needed on safety operational topics.

• 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.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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.

Experience/The Ideal for Successful Entry into Job:

• BS or MS in Nursing, Pharmacy or other clinical degree with a minimum of eight years of clinical experience.

• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.

• Experience using Argus safety database preferred.

• Clinical trial and spontaneous adverse event processing experience.

Knowledge/Skills:

• 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.

• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.

• Demonstrates clear and effective verbal and written communication.

• Works collaboratively with team members to achieve alignment. Engages stakeholders to establish collaborative relationships.

• Good interpersonal skills and emerging ability to bring differing views to develop an agreed upon resolution.

• Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members.

• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data.

• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

• Anticipates, identifies, prioritizes, and resolves task-related challenges, and escalates issues as needed.

• Creates formal networks involving coordination within the Global Patient Safety department and with cross-functional teams.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work.

#LI-MB1