Drug Safety Associate II – Iovance Biotherapeutics Inc – San Carlos, CA

Overview

The Drug Safety Associate II candidate works in a team-oriented, dynamic, and collaborative environment. This person would manage the drug safety mailbox, track case workflow, support the drug safety activities while adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures. Ensures compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country, and regional regulations for the reporting of adverse events to regulatory agencies.

Specific Responsibilities:

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

• Supports all clinical safety (CS) and pharmacovigilance (PV) aspects of Iovance clinical studies and post market products
• Monitor and manage safety inbox including archiving of emails and documents
• Update and manage various Workflow as well as submission trackers
• Review triage assessments and monitor the incoming reports
• Performs case management including receipt, duplicate check, book-in, assessment of seriousness and expectedness, data entry and narrative writing
• Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries
• Review data to ensure case accuracy with minimal error in narratives
• Review MedDRA and WHODrug coding as needed
• Review, enter, and verify follow-up information for cases and make accurate determination of significant information
• Perform review of ancillary documentation accompanying ICSR reports and identify pertinent information for incorporations into the case narrative
• Correctly identify cases requiring targeted follow-up, and determine relevant follow-up queries
• Meet specific data and quality targets for case handling
• Liaise with safety physicians, medical monitors, sites, clinical department, affiliate, vendor, or other organizations as needed on safety data issues
• Recognize situations that require assistance from more senior staff members or Safety Physicians and seek assistance from appropriate internal resources
• Demonstrates general understanding of appropriate labeling documents for study products
• Organizes workload to ensure departmental workflow processes and timelines are followed
• May assist manager with other projects including but not limited to the preparation of training materials, global PV system compliance and vendor management activities
• May support PV Audit and Inspection preparation
• May participate in other activities, as needed or as requested by the supervisor
• Remain current with Iovance SOPs, guidance documents and database technology
• May perform Quality Control on other team member’s work
• Able to work independently and prioritize workload
• Other duties as assigned

Education and Qualifications:

• Healthcare professional degree (i.e., RN, PharmD) with minimum of 1year professional experience or Bachelors’ degree in life sciences or equivalent relevant scientific qualifications with minimum of 3 years of experience in drug safety
• Knowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
• Excellent interpersonal and communication skills, both written and oral
• Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
• Safety database and case processing experience preferred
• Oncology experience or knowledge preferred
• Ability to assess data and understand the medical/safety implications
• Demonstrates initiative, teamwork and accountability
• Demonstrated success working both independently and in collaboration with others
• A quality driven individual with strong attention to detail and accuracy is required
• Strong organizational skills, and ability to adapt to change
• Ability to follow guidelines and procedural documents
• Self-motivated and capable of working independently
• Understands safety database structures and is familiar with data retrieval tools is preferred

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