Drug Safety Analyst

Job Summary The Drug Safety Analyst provides operational support for global pharmacovigilance activities for Company's investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data analysis and management obtained from the integrated database utilized by worldwide Company pharmacovigilance personnel. The personnel who cover the workplace will develop their activities according to the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) and following the Pharmacovigilance legislation location: Los Angeles, California job type: Contract salary: $42 - 45 per hour work hours: 9 to 5 education: Bachelors Responsibilities • Aggregate Reporting & Data Analysis: Lead the end-to-end extraction, review, and processing of safety data to develop high-quality aggregate reports and respond to global regulatory inquiries. • Safety System Administration: Act as the technical subject matter expert for PV database configurations, managing updates for submission rules, product studies, and user-requested system improvements. • Signal Management & Detection: Serve as a Signal Analyst, executing complex data extractions for signal detection reports and ensuring all documentation meets strict filing and archiving standards. • System Implementation & Change Management: Drive the integration of new PV applications by defining user requirements, technical specifications, and process flow diagrams to ensure a smooth team transition. • Compliance & Audit Readiness: Ensure all PV activities align with PSMF, SOPs, and global legislation; actively participate in self-inspections, regulatory audits, and CAPA management. • Cross-Functional Collaboration: Partner with Regulatory Affairs and IT to verify system changes, manage safety document submissions, and provide technical training to global stakeholders. • Support drug safety applications with business administration tasks. Key project team technical expert to deliver solutions that are cost effective, sustainable, and meet business requirements Scientific and medical literature review • Define with the Knowledge Services Department the strategy of scientific searches that are performed • Review scientific literature and bibliographic search results and determine the actions necessary to be taken therewith Qualifications Education: University degree in Health/Life Sciences (with IT training) OR an IT degree (with direct Pharmacovigilance experience). Domain Expertise: 2+ years of dual experience in Pharmacovigilance (PV) and Database Management, including familiarity with MedDRA/WhoDrug coding. Technical Proficiency: Hands-on experience with Safety Systems (E2B R2/R3), CSV/GMP validation, and data reporting tools (e.g., Business Objects). Communication & Travel: Strong technical writing skills for test scripts/SOPs and availability for occasional international travel. skills: Drug Safety Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. u9000033931