• Reviewing test requisition forms and clinical notes, extracting clinical information into structured data, such as HPO terms • As needed, opportunities for cross-training in WGS variant curations or WGS report writing may become available

• Review test requisition forms and clinical notes • Perform case analysis using the Emedgene platform • Identify and select variants relevant to the proband’s phenotype • Request confirmatory testing when necessary • Communicate findings at cross-team huddles • Opportunities for cross-training in WGS variant curations or clinical indication may become available as needed

• 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.

• Take accountability for proactively driving clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence. • Drive communication and collaboration with the client and project team across a matrixed, multicultural, environment. • Lead the development of the clinical project strategy and ensures prioritization with the clinical project team and key stakeholders in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality and budget. • In collaboration with relevant departments, prepare and deliver presentations for new business as required. • Manage the operational aspects of projects to support subject recruitment and retention, clinical vendor delivery and oversee the monitoring visit strategy. • Identify clinical project, financial and quality risks leveraging end to end risk management practices and quality by design principles. • Appropriately utilize data sources, dashboards and risk management strategies to drive innovation and proactive problem solving with the project and client teams. • Adhere to project governance and issue escalation pathways, ensuring that clinical project plans are in place to address identified risk while adhering to professional standards, SOPs, client and regulatory requirements • Partner with project team members and key stakeholders to oversee and manage clinical project budgets, resources and scope. • Ensure adherence to established budget and financial milestones. • Accountable for accurately forecasting clinical project revenue and managing project costs in adherence to the budget. • Leading the timely management of changes to scope and the change order process. • Ensures project team awareness and tracking of KPIs for any client specific metrics. • Provide inspiring leadership and play a key role in the creation of high performing clinical project teams. Facilitating communication and teamwork while driving delivery, ensuring that clinical team members understand contracted scope, timelines and budget. • Ensures that clinical resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. • Develops and mentors team members in multiple areas of expertise and provide feedback as needed to respective line managers • As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking, and documentation. • Support new business with active participation in Bid Defense preparation and meetings, as required. • And all other duties as needed or assigned