Drug Safety Specialist II - West Coast

Position Summary Responsibilities will include, but may not be limited to: safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel. Essential Functions Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems. Participate in the assessment and set-up of a safety database to capture SAE data. Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures. QC of documents and safety reports. Preparation and/or review of project‑specific safety reporting plans and medical coding plans. Preparation and/or review of safety training materials. Provide safety training and oversight for consultants, contractors and/or staff. Review and/or draft standard operating procedures and work instructions. Assist clients and/or other departmental staff with safety‑related reviews and other services. Other duties as assigned. Qualifications Minimum Required BA/BS degree Minimum 2 years safety experience Other Required Health care professional Hands‑on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation Working knowledge of MedDRA and WHODrug Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations. Preferred Nursing or pharmacy degree preferred Clinical trial safety experience Hands‑on experience with Argus Industry experience in CRO or pharmaceutical company preferred Compensation and Benefits Precision is required to provide a reasonable estimate of the compensation range for this role. Reasonable estimate of the current range: $75,600 USD – $113,400 USD. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Equal Opportunity Employer Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Recruitment Fraud Warning Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at View email address on click.appcast.io so we can investigate and take appropriate action. #J-18808-Ljbffr Precision Medicine Group