Drug Safety Associate

Overview

The Drug Safety Associate supports the day-to-day operations and documentation needs of clinical safety and pharmacovigilance work. Partnering closely with the Drug Safety Manager, this position helps maintain prompt, accurate, and compliant safety oversight across multiple studies managed with CRO partners.

Key Responsibilities

• Monitor the flow, current status, and reporting progress of safety cases across clinical studies using sponsor and CRO systems.
• Check safety output for completeness, internal consistency, and alignment with each study’s requirements.
• Help reconcile clinical and safety databases and keep a clear record of checks and any resolutions.
• Keep safety logs, trackers, training files, deviation records, action-item lists, and related records up to date.
• Coordinate the collection, version control, and archiving of safety documents in the TMF and other safety files.
• Plan and document safety review meetings, including agendas, meeting notes, attendance, and follow-up tasks.
• Liaise with CROs, vendors, and internal teams on meetings, deliverables, deadlines, and escalation items related to safety.
• Maintain safety contact lists, distribution lists, routing instructions, templates, checklists, and forms.
• Help prepare for audits and inspections by assembling supporting evidence and oversight documentation.
• Assist in implementing and documenting CAPAs connected to safety processes.
• Create slides, summaries, and other administrative materials for Safety and clinical teams.
• Handle additional tasks as assigned.

Education and Experience

• A bachelor’s degree in Nursing, Pharmacy, Public Health, Biomedical Sciences, Life Sciences, or a closely related healthcare or scientific field.
• Clinical credentials or healthcare certifications such as RN, PharmD, or PA are preferred.
• About 1–3 years of relevant experience in clinical research, drug safety/pharmacovigilance, clinical trial coordination, clinical data management, or a related role in biotechnology, pharmaceuticals, or a CRO setting.

Skills and Knowledge

• Solid understanding of clinical trial operations and safety reporting concepts such as SAE, SUSAR, MedDRA, and ICH GCP, along with an interest in building pharmacovigilance expertise.
• Excellent attention to detail, accuracy, and organization, with the ability to manage several trackers, documents, deadlines, and timelines at once.
• Strong working knowledge of Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook, plus file-sharing and online meeting platforms.
• Ability to quickly learn new systems, dashboards, and workflows.
• Clear written and verbal communication skills and the ability to work well across functions in a small, fast-moving team.
• Prior exposure to drug safety or pharmacovigilance operations, including case tracking, TMF filing, safety meeting coordination, and coordination with CRO partners.
• Experience in an early-stage biotechnology company or another dynamic, growth-focused environment.

Equal Opportunity and Employment Eligibility

Viking Therapeutics provides equal employment opportunity to all employees and applicants. Hiring and employment decisions are made without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. The company also follows all applicable federal, state, and local nondiscrimination laws, as well as work authorization and employment eligibility verification requirements under the Immigration and Nationality Act and IRCA.

Agency and Search Firm Notice

The company is not accepting unsolicited resumes from agencies or search firms for this opening. Resumes sent to any Viking employee by a third-party agency or search firm without a valid written and signed agreement, and without an assignment to this specific position, will become the property of Viking Therapeutics, Inc. No placement fee will be paid for candidates hired as a result of an unsolicited referral.

Compensation

The annual salary range for this role is $77,000 to $90,000.