Safety Database Specialist – Clinical Trial Drug Safety Associate I

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Support the day-to-day running of Argus Safety to sustain Drug Safety objectives, with emphasis on safety database development and administration activities and expanding new services within Argus reporting capabilities and efficiencies. • Assist with project specific configurations in Argus Safety for new clients, products, and studies in the development, validation, and production environments. • Perform post go-live changes (database modifications) for existing studies based on required changes. • Update and maintain the technical specifications documentation for Argus (Configuration Specifications Document [CSD]) for each new change control (new or updated configuration). • Develop UAT scripts for new study builds or database modifications; lead the safety teams for UAT validation activities to maintain validation documentation in accordance with governing documents. • Review the protocol and associated reference material and contribute to the development of the database development project timeline. Maintain database development timelines and promote good project management practices. • Assist Pharmacovigilance and Drug Safety in planning, directing, and managing the safety database development and maintenance process. • Assist with the design and development of the Argus Bridge application to integrate safety data from EDC to Argus for selected sponsor studies, including: 1) Research and analysis of safety data integration requirements and standards. 2) Programming architecture design. 3) Building data acquisition bridges from RESTful web services and other application programming interfaces. 4) Full stack development of program for data cleaning, transformation, selection, and transfer. 5) Configure Argus database for data integration compatibility. 6) Employ SVN (Apache Subversion) software version control. 7) Deploy applications in Linux server. • Assist with the design and development of project deliverables, conducting routine and ad hoc data extractions from Argus including line listings (6-month line listings or other case listings) for reporting to sponsors, business partners, and regulatory agencies, aggregate reports, and Development Safety Update Reports (DSURs). • Learn and perform data search strategies in Oracle Argus Insight and/or Business Intelligence Publisher, using search queries to search the data mart to retrieve case series, and create custom and standardized reports (compliance reports, metric reports). • May learn to write PL/SQL (Procedural Language for Structured Query Language) queries for data extraction, advance conditions, ad hoc queries, and custom reports, to meet internal business requirements. • May write stored PL/SQL procedures to modify incoming and outgoing data value and structures. • Support initiatives for efficiencies in PV processes, including but not limited to, generation of autonarratives during case processing, standardized and custom reports from Argus or Argus Insight, and metric reports. • Support Dictionary version management (MedDRA, WHO) and future database upgrade activities. • Assist with the preparation of documents such as status reports, data flow diagrams, SOPs, Work Instructions, training materials, and user manuals related to database development and administration. • As needed, provide support to case processing of serious adverse events (SAEs) and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members. • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting. • Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows. • Keep current with industry best working practices in PV/medical device vigilance (MDV) guidance(s) and regulatory requirements, industry trends, benchmarking, and best working practices in safety database development by reading and participating in relevant training, and/or related activities. • Review, assess, and process cases from clients’ ongoing drug or device clinical trials. • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines. • Perform training of study related materials related to case processing of individual case study reports (ICSRs) for a clinical trial, including the study protocol and Safety Management Plan (SMP). • Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements. • Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements. • Perform quality control (QC) review of case processing by other PV personnel. 1) Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary. 2) Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents. 3) Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and is up-to-date, complete, and concise. 4) Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites. 5) Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus. 6) Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements. • May generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs). • May also perform a data entry role in ICSR case processing, including generation of the case narrative. • Participate in the design of SAE report forms for the capturing of safety data in clinical trials. • Review study-specific SMPs written by other PV personnel; occasionally draft SMPs. • Perform reconciliation of safety data between clinical and safety databases. • Perform UAT of safety database builds to ensure validation of the study and reporting configuration. • May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary. • Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting. • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting. • Keep current with industry best working practices in PV/MDV guidance(s) and regulations. • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

🎯 Requirements

• Bachelor of Science (or equivalent) degree in Clinical or Medical or Life Sciences. • Two years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or Clinical Research Organization environment. • Prior technical background and experience with Oracle Argus Safety, including case processing and generating reports/line listings from the database. • Familiar with E2B (XML) format for safety reporting to regulatory agencies. Knowledge of E2B electronic data exchange. • Experience preferred in related, underlying technologies, including SQL, Oracle, XML, and integration technologies and standards. • Preferred: skills in report generation using business intelligence tools (Argus Safety/Argus Insight) • Ability to troubleshoot complex problems, involve multiple teams/departments in the investigation and assessment of the problem and proposed solutions. • Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/Good Pharmacovigilance Practices (GVP)/ICH safety guidelines for investigational and marketed products. Global PV regulation experience is preferred. • Ability to work independently with little supervision; self-motivated and productive. • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. • Strong verbal and written communication skills with the ability to understand and summarize medical terminology. • Detail-oriented, customer- and quality-focused. • Strong attention to detail. • Excellent interpersonal and teamwork skills. • Computing skills in Microsoft Office applications. • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data. • Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off