• Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. • Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved • Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects • Participates in audits/inspections as required • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process • Attends Department meetings • Participates in project specific teleconferences/meetings as required • Other duties assigned by management

• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects • Participates in audits/inspections as required • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process

• Lead safety strategy and compliance efforts that protect people, facilities, and mission-critical operations nationwide. • Support GSA’s national safety program by providing expert guidance, policy interpretation, and oversight across a nationwide portfolio. • Serve as a subject matter expert in occupational safety, compliance, and risk management while supporting inspections, training, and program development. • Provide expert guidance on occupational safety, hazard control, and regulatory compliance. • Conduct inspections, investigations, and risk assessments; develop corrective action plans. • Investigate incidents, identify root causes, and recommend preventive measures. • Review construction and project plans to ensure safety compliance. • Develop and deliver safety policies, guidance, and training programs. • Support national safety program tracking, reporting, and continuous improvement. • Represent GSA in meetings with agencies, regulators, and stakeholders. • Maintain safety data, records, and compliance with federal standards.

• Manage the deployment processes of Motorola’s public safety and command center software suite within complex software ecosystems for public safety agencies. • Lead the efforts to conduct operational assessments, business process reviews, and other discovery events to gain a comprehensive understanding of the customer’s current business processes within Public Safety agencies. • Evaluate existing business processes to identify opportunities for improvement. • Facilitate business process reengineering initiatives by analyzing workflows and recommending innovative changes. • Design, develop, and deliver training curriculum, learning aids, and other instructional materials to ensure end-user engagement and buy-in for new software implementations. • Define, coordinate, and lead User Acceptance Testing processes, ensuring that customer requirements are met and documenting results against the project’s Functional Requirements Matrix. • Act as a liaison between technical resources, engineers, and project managers to communicate customer needs effectively. • Partner with Project Managers and Program Directors throughout the project lifecycle.