Overview We are currently searching for a skilled professional to join a well-known client’s team as a Temporary Drug Safety Associate III in Alameda, CA. The Temporary Drug Safety Associate III role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. Responsibilities Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing. MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization. Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician. Scheduling submissions of expedited safety reports in ARGUS as needed. Training of new safety staff on Argus and case processing. Collaborating with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data. Performing Safety Study Lead activities including: Review of Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician. Development of study specific safety management plan from Drug Safety template. Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF). Perform SAE reconciliation, as required by safety management plan. Additional duties and responsibilities as required. Experience & Education BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or, MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or, PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience To Be a Best-fit Your Strengths Must Include Knowledge of biotechnology/pharmaceutical sector. Knowledge of regulatory framework governing patient safety. Adopts an analytical approach to solve problems relevant to the role. Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work. Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals. Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner. Works collaboratively with team members. Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolution. Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. #J-18808-Ljbffr Advanced Clinical
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