Safety Intern

Job title and summary Pharmacovigilance Intern – Summer 12‑Week Program The Pharmacovigilance Intern will support the Drug Safety/Pharmacovigilance (PV) team in adverse event case management, safety data review, and regulatory reporting activities while participating in a structured 12‑week training curriculum. The role is designed to provide hands‑on experience with PV processes, tools, and global regulations from both pre‑ and post‑marketing settings. Key responsibilities Participate in review and training on pharmacovigilance standard operating procedures (SOPs), Good Clinical Practice (GCP) modules, and internal processes. Undertake a historical case study and literature‑based activity (e.g., Thalidomide and other landmark safety events) to understand the evolution of drug safety and why PV matters. Assist with classification of adverse events and adverse drug reactions, including assessment of seriousness, severity, expectedness, and basic causality under supervision. Support periodic and expedited reporting activities by helping map timelines, organize source documentation, and review key regulatory guidance excerpts (e.g., ICH E2A–F, FDA/EMA/MHRA requirements). Assist with safety database–related tasks (e.g., Argus demo/screenshot‑based exercises, basic data quality checks, and audit trail review) as assigned. Participate in introductory signal detection and signal management activities, including data visualization exercises, FAERS dashboard exploration, and literature search support. Observe or support internal signal review or safety review meetings (e.g., Medical Safety Team), including preparation or review of meeting materials and trackers. Complete a capstone project (e.g., focused safety topic, regulatory guideline summary, or signal evaluation case study) and present findings to the PV team at the end of the internship. Assist with additional PV activities such as review of study protocols, investigator brochures, safety management plans, DSUR content, PV mailbox management, and navigation of PV SharePoint or equivalent systems as needed. Learning objectives By the end of the internship, the intern will be able to: Define pharmacovigilance, describe its scope, and articulate the role of PV across the drug development lifecycle, including pre‑ and post‑marketing surveillance. Identify key PV stakeholders (e.g., FDA, EMA, MHRA, WHO, healthcare professionals, patients) and describe their roles in the global safety ecosystem. Distinguish between adverse events and adverse drug reactions and classify events by seriousness, severity, expectedness, and basic causality frameworks (e.g., WHO‑UMC). Demonstrate understanding of core global PV regulations, including ICH E2A–F, expedited safety reporting timelines, and periodic reporting concepts (e.g., DSUR, PSUR, PADER). Explain basic concepts of signal detection, evaluation, and management, including use of safety databases and dashboards for signal exploration and benefit‑risk assessment. Understand potential career paths in pharmacovigilance and related functions, and identify relevant professional organizations (e.g., ISoP, DIA) and resources for continued development. Qualifications Current enrollment in a bachelor’s, master’s, PharmD, MD, nursing, public health, or related life science program (e.g., pharmacology, toxicology, epidemiology, biostatistics). Strong interest in drug safety, clinical research, or regulatory science, with motivation to pursue learning in pharmacovigilance. Basic understanding of clinical research concepts and medical terminology; prior coursework in pharmacology or related fields preferred. Excellent written and verbal communication skills, with attention to detail and comfort working with structured templates and guidelines (e.g., SOPs, regulatory documents). Ability to work collaboratively in a cross‑functional setting, manage multiple tasks, and seek guidance appropriately. Location: Brisbane, California, hybrid, or remote. Reporting line: Reports to a Pharmacovigilance Scientist/Physician or Drug Safety Manager with mentorship from assigned PV team members. Structure: Mix of formal training sessions, guided self‑study, hands‑on case‑based exercises, meeting participation, and a final capstone project and presentation. #J-18808-Ljbffr