• Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel. • Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems. • Participate in the assessment and set-up of a safety database to capture SAE data. • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures. • QC of documents and safety reports. • Preparation and/or review of project-specific safety reporting plans and medical coding plans. • Preparation and/or review of safety training materials. • Provide safety training and oversight for consultants, contractors and/or staff. • Review and/or draft standard operating procedures and work instructions. • Assist clients and/or other departmental staff with safety-related reviews and other services. • Other duties as assigned.

• Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel. • Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems. • Participate in the assessment and set-up of a safety database to capture SAE data. • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures. • QC of documents and safety reports. • Preparation and/or review of project-specific safety reporting plans and medical coding plans. • Preparation and/or review of safety training materials. • Provide safety training and oversight for consultants, contractors and/or staff. • Review and/or draft standard operating procedures and work instructions. • Assist clients and/or other departmental staff with safety-related reviews and other services. • Other duties as assigned.

• 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