Drug Safety Manager

Description:

The Drug Safety Manager (DSM) is responsible for study and compound level safety oversight across early and late-stage clinical programs in collaboration with internal medical monitors, multidisciplinary / cross-functional teams within the organization, and external CRO partners. This role ensures high quality safety data, compliant case management, and robust safety surveillance.

Essential Duties and Responsibilities

The responsibilities of this role include but are not limited to the following:

Study and program safety oversight

• Serve as safety lead for assigned clinical studies (Phase 1–3), partnering with Clinical Development, Clinical Operations, and CRO safety teams.
• Provide safety input into protocols, informed consent forms, IB safety sections, safety management plans, and monitoring plans.
• Ensure safety sections of key clinical documents (protocol amendments, CSR safety narratives/sections, DSURs) are accurate and internally consistent before senior/medical sign off.

CRO oversight and case management quality

• Oversee CRO performance in ICSR case processing, MedDRA and WHO Drug coding, and expedited/periodic reporting according to study plans and global regulations.
• Review periodic line listings, case narratives, and coding outputs; identify trends, quality issues, and areas requiring corrective action.
• Participate in regular safety operations/governance meetings with CROs; track KPIs, issues, and action items through resolution.

Safety surveillance and signal support

• Contribute to ongoing medical review/surveillance by preparing safety data summaries (e.g., line listings, frequency tables, figures) for internal safety reviews and signal meetings.
• Support identification and characterization of potential safety signals in partnership with Sr. Safety Manager and medical monitors.
• Draft or contribute to risk assessments, mitigation proposals, and safety sections of aggregate reports (e.g., DSURs, periodic safety updates).

Cross functional collaboration

• Work closely with internal medical monitors/physicians to support causality and seriousness assessments, especially for complex or medically significant cases.
• Partner with Clinical Operations on SAE reporting expectations, site training content, and reconciliation between clinical and safety databases.
• Provide safety input into study start up activities (site training materials, safety reporting language, vendor plans).

Compliance, quality, and inspection readiness

• Contribute to the development, implementation, and maintenance of safety related SOPs, work instructions, and templates.
• Assist in preparation for, and participation in, internal audits and health authority inspections involving safety and pharmacovigilance.
• Ensure accurate and timely documentation and filing of safety related materials in the Trial Master File and safety system files.

Requirements:

Education and Experience

• Bachelor’s degree in Nursing, Pharmacy, Public Health, Biomedical Sciences, or related healthcare/scientific field required.
• Preferred: RN, PharmD, PA, or other clinical credential.
• Approximately 5–8 years of experience in drug safety/pharmacovigilance in a biotech, pharma, or CRO environment, including experience with interventional clinical trials.

Knowledge and Skills

Required

• Solid understanding of global PV regulations and ICH GCP, including SAE/SUSAR reporting requirements and aggregate reporting.
• Demonstrated experience with CRO oversight and review of case processing outputs, MedDRA coding, and safety documentation.
• Strong analytical skills with ability to review and interpret clinical and safety data and identify trends.
• Excellent communication and collaboration skills with the ability to work in a small, fast-paced, cross-functional environment.
• High degree of proficiency with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook), file sharing software, online conferencing applications, and comfort learning new systems and dashboards.
• Strong communication skills and ability to work effectively in a small, collaborative team.

Preferred

• Experience supporting Phase 3 clinical programs and/or registrational intent trials.
• Experience with safety database outputs and basic familiarity with signal detection tools or methodologies.
• Prior exposure to inspections or audits involving PV.
• Experience in an early-stage biotech or similarly dynamic environment.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.