Drug Safety Analyst

Details for the position are as follows: • Rate: $42-45 an hour • Location: Los Angeles, CA 90032 - 100% onsite • 12-month contract to start with possibility of extension or conversion depending on performance and business needs Job Description: • The position is responsible for safety data analysis and management within the integrated pharmacovigilance database used by global PV personnel. The Drug Safety Analyst supports system implementation, ongoing system improvements, and business support activities while collaborating closely with IT system administrators to validate and test system changes to ensure regulatory compliance and alignment with business needs. • Process, analyze, review, and evaluate safety data to support the preparation of aggregate safety reports. • Perform data extraction and analysis from pharmacovigilance databases to support PV documentation and reporting. • Coordinate and manage creation of database queries used for pharmacovigilance documentation. • Support responses to regulatory authority requests related to safety data. • Participate in signal management activities, including acting as Signal Analyst and generating signal detection reports. • Ensure proper documentation, filing, and archiving of safety data outputs. • Ensure PV activities comply with global pharmacovigilance legislation and regulatory requirements. • Support preparation and submission of aggregate safety reports and communicate submission status to Regulatory Affairs and relevant business partners. • Collaborate with Regulatory Affairs on safety documentation required by regulatory authorities. • Monitor pharmacovigilance legislation to ensure ongoing regulatory compliance. • Participate in pharmacovigilance audits, inspections, self-inspections, and CAPA management. • Support configuration updates in the pharmacovigilance database including: Regulatory submission rules, Product and study information • Lead or support change management initiatives to facilitate adoption of new PV processes or applications. • Collect, prioritize, and implement system improvement requests from users while ensuring regulatory compliance. Required Skills: • Bachelor's degree required • 2+ years of Drug Safety experience required • Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA,WhoDrug is beneficial • Pharmacovigilance Systems & Database Administration HIGHLY preferred • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Visio). By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy