Safety Database Specialist – Clinical Trial Drug Safety Associate I

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Assist in the daily operations of Argus Safety to uphold Drug Safety goals, focusing on the development and management of the safety database while enhancing new services within Argus reporting capabilities and efficiencies.

• Support project-specific configurations in Argus Safety for new clients, products, and studies within development, validation, and production environments.

• Execute post go-live modifications (database changes) for existing studies as required.

• Revise and maintain the technical specifications documentation for Argus (Configuration Specifications Document [CSD]) for each new change control (new or updated configuration).

• Create UAT scripts for new study builds or database alterations; lead safety teams in UAT validation activities to ensure validation documentation complies with governing documents.

• Analyze the protocol and relevant reference materials, contributing to the database development project timeline. Maintain database development timelines and promote effective project management practices.

• Collaborate with Pharmacovigilance and Drug Safety to plan, direct, and oversee the safety database development and maintenance process.

• Participate in the design and development of the Argus Bridge application to merge safety data from EDC to Argus for selected sponsor studies, including: 1) Research and analysis of safety data integration requirements and standards. 2) Designing programming architecture. 3) Building data acquisition bridges from RESTful web services and other APIs. 4) Full-stack development for data cleaning, transformation, selection, and transfer. 5) Configure the Argus database for compatibility with data integration. 6) Utilize SVN (Apache Subversion) for software version control. 7) Deploy applications on Linux servers.

• Assist in designing and developing 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, as well as aggregate reports and Development Safety Update Reports (DSURs).

• Acquire knowledge and perform data search strategies in Oracle Argus Insight and/or Business Intelligence Publisher, using search queries to access the data mart for retrieving case series and creating custom and standardized reports (compliance reports, metric reports).

• May learn to write PL/SQL (Procedural Language for Structured Query Language) queries for data extraction, advanced conditions, ad hoc queries, and custom reports to fulfill internal business requirements.

• May draft stored PL/SQL procedures to modify incoming and outgoing data values and structures.

• Support initiatives aimed at enhancing efficiencies in PV processes, including but not limited to the generation of autonarratives during case processing, standardized and custom reports from Argus or Argus Insight, and metric reports.

• Aid in managing Dictionary version control (MedDRA, WHO) and future database upgrade activities.

• Assist in preparing documents such as status reports, data flow diagrams, SOPs, Work Instructions, training materials, and user manuals related to database development and administration.

• Provide timely support for the case processing of serious adverse events (SAEs) and/or pregnancy reports from clients’ ongoing drug clinical trials, 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.

• Serve as a training resource for staff on case processing and the use of the Argus Safety System and related case processing workflows.

• Stay updated with industry best practices in PV/medical device vigilance (MDV) guidelines and regulatory requirements, including industry trends, benchmarking, and best practices in safety database development through reading and participation in relevant training and activities.

• Review, evaluate, and process cases from clients’ ongoing drug or device clinical trials.

• Conduct PV and MDV activities for clients in compliance with company SOPs, operational practices, and regulatory guidelines.

• Train on study-related materials concerning case processing of individual case study reports (ICSRs) for clinical trials, including the study protocol and Safety Management Plan (SMP).

• Perform PV activities promptly in accordance with regulatory and sponsor reporting requirements.

• Act as the Lead Safety Associate for assigned trials, ensuring all PV requirements are met.

• Conduct quality control (QC) reviews of case processing by other PV personnel: 1) Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure necessary redaction of personal identifying information. 2) Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects relevant case details from source documents. 3) Review patient narratives to ensure adherence to the narrative template and that they are up-to-date, complete, and concise. 4) Generate queries for any critical or missing information and send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) for direct queries to study sites. 5) Ensure that all case documentation is filed and saved correctly, including uploading source files into Argus. 6) Collaborate with the Everest Medical Monitor to guarantee the high quality of case narratives and regulatory report forms in line with 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 take on a data entry role in ICSR case processing, including generating case narratives.

• Engage in the design of SAE report forms for capturing safety data in clinical trials.

• Review study-specific SMPs written by other PV personnel and occasionally draft SMPs.

• Perform reconciliation of safety data between clinical and safety databases.

• Conduct UAT of safety database builds to ensure validation of study and reporting configurations.

• May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other necessary documents.

• 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.

• Stay informed about industry best practices in PV/MDV guidance(s) and regulations.

• Plan and manage deliverables and timelines to align with the clinical trial project teams’ requirements.

⛳️ Requirements

• Bachelor of Science (or equivalent) degree in Clinical or Medical or Life Sciences.

• Two years of relevant work experience in Drug Safety/Pharmacovigilance within a pharmaceutical or Clinical Research Organization environment.

• Background and experience with Oracle Argus Safety, including case processing and generating reports/line listings from the database.

• Familiarity with E2B (XML) format for safety reporting to regulatory agencies, along with knowledge of E2B electronic data exchange.

• Preferred experience 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 issues, involving multiple teams/departments in the investigation and assessment of problems 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, with global PV regulation experience preferred.

• Capability to work independently with minimal supervision; self-motivated and productive.

• Strong organizational skills, able to adapt to changing priorities and manage multiple assignments with challenging/conflicting deadlines.

• Excellent verbal and written communication skills, with the ability to comprehend and summarize medical terminology.

• Detail-oriented, with a focus on customer service and quality.

• Strong attention to detail.

• Exceptional interpersonal and teamwork abilities.

• Proficient in Microsoft Office applications.

• Ability to maintain a high degree of confidentiality with clinical data and clients' proprietary data.

• Proven flexibility and adaptability when collaborating in a team or working independently, exercising good judgment in decision-making is preferred.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off