Tiffany Coles Email and Phone Number

• Managed the PICI drug safety/pharmacovigilance operational strategy• Managed the PICI pharmacovigilance activities for PICI clinical trials• Provided pharmacovigilance and risk management planning for designated trials by analyzing the risks of the agents involved, preparation of safety strategies for US in prep for Global expansion and highlighting and tracking potential issues • Reviewed and provided clinical scientific input to TLFs and patient safety narratives• Provided development support for clinical plans and individual study protocols• Supported the preparation and maintenance of safety sections in the Clinical Protocols• Reviewed Pharmacovigilance analytics for the purposes of cohort expansion• Developed the Safety Management Plan (SMP) and Medical Monitoring Plan (MMP) • Worked with the study team to ensure the provision of protocol-specific site training • Reviewed scientific literature• Worked cross functionally in the implementation and conduct of clinical trials which includes but is not limited to review of enrollment packets, review of adverse events and all other clinical data generated during conduct of trial • Facilitated and assisted in Medical Monitor responsibilities • Ensured that all relevant clinical and safety data is collected in a timely manner and assist with cleaning of data listings • Provided safety vendor oversight with training, guidance and KPIs• Established a safety program budget• Performed safety database validation

• Provide leading strategy development and planning• Provide global PV oversight of a vendor PV team• Prepare RFPs and budget for PV vendor• Prepare annual budget for PV department• Perform compliance monitoring of safety processes utilizing monthly& periodic metrics• Develop Medical Monitor training• Develop protocol language for various safety issues (i.e.pregnancy reporting, new cancers & worsening disease related events) • Develop PV plans:Risk Management, Medical Monitoring,and Safety Management Plans• Establish work processes for AE/SAE Reconciliation, MedDRA and WhoDRUG Coding Review• Utilize global safety DB and other tools to analyze reports for signaling/risk management and regulatory reporting information.• Prepare documentation for FDA medical review of regulatory processes• Assess SAE reports for serious criteria according to applicable SOP, ICH and Global Health authority regulations• Ensure that all SAEs are triaged, scheduled, processed & reported accordingly per global requirements• Review clinical study data and medical coding on an ongoing basis• Ensure ongoing SAE reconciliation between Safety and Clinical databases• Prepare Analysis of Similar Events for related SUSAR reports• Communicate with partners, vendors, and internal group regarding processing and timely exchange of safety reports

• Develop Medical Monitor training• Develop protocol language for various safety issues (i.e.pregnancy reporting, new cancers & worsening disease related events) • Develop PV plans:Risk Management, Medical Monitoring,and Safety Management Plans• Establish work processes for AE/SAE Reconciliation, MedDRA and WhoDRUG Coding Review• Utilize global safety DB and other tools to analyze reports for signaling/risk management and regulatory reporting information.• Prepare documentation for FDA medical review of regulatory processes• Assess SAE reports for serious criteria according to applicable SOP, ICH and Global Health authority regulations• Ensure that all SAEs are triaged, scheduled, processed & reported accordingly per global requirements• Perform compliance monitoring of safety processes utilizing monthly& periodic metrics• Review clinical study data and medical coding on an ongoing basis• Ensure ongoing SAE reconciliation between Safety and Clinical databases• Prepare Analysis of Similar Events for related SUSAR reports• Communicate with partners, vendors, and internal group regarding processing and timely exchange of safety reports• Perform & provide oversight for day-to-day interaction with PV vendor(s) and others, where applicable• Identify & follow-up on CAPAs arising from audits and inspections related to PV• Work closely with Clinical Operations, CROs, Data Management, Safety Physician, Study Physicians to ensure all clinical trial activities with data collection and data cleaning is done• Prepare & review queries to obtain critical or missing data on SAE forms • Safety system manager and perform individual case processing • Project lead for implementing a new 21CFRPart 11 compliant eDMS• Create Risk Mitigation and Contingency Plan for the migration of data • Development of SOPs

• Perform daily MedDra coding of Serious Adverse Events• Develop, prepare and present MedDRA training sessions• Generate and send MedDRA queries to clinical trial sites when required• Collaborate with internal and external clientele on process development and improvement• Revise and edit database system SOPs and PWIs• Revise and implement project specific QC procedures • Coordinate and lead face-to face client support meetings o Working group meetings o Stakeholder data management meetings o MedDRA meetings o Safety and Pharmacovigilance team meetings• Report, review, and data enter Serious Adverse Events (SAEs) received from clinical sites into the safety database• Transcribe case narratives from reported SAE information• Perform medical and data quality checks on peer SAE case narratives• Query sites for clarification or error in information on SAE forms and perform follow-up procedures when required• Perform regulatory obligations towards pharmaceutical companies according to agreed clinical trial agreements • Respond to queries from pharmaceutical companies• Perform System Validation and User Acceptance testing on coding safety database (ARGUS)• Generate ad hoc line listings requests from the safety database.• Generate and/or QC aggregate reports• Coordinate reconciliation and protocol implementation meetings with client and key personnel for new and upcoming vaccination studies

• Responsible for planning, monitoring, and coordinating clinical research studies at external trial sites• Review protocols with internal and external project personnel to determine data collection requirements• Analyze data integrity checks functionality• Collaborate with Protocol Team leads on mid-point and end-point data review and analysis from primary and secondary patient data• Perform data quality checks for completeness and accuracy• Design, develop and maintain Case Report Forms (CRFs) and Patient Surveys• Assist with development of basic database queries, reports, and other data related activities• Perform ongoing review of protocols, Informed Consents and IRB submissions• Collaborate with internal and external team members to improve study conduct and assure compliance with study procedures• Track site enrollment and site performance information• Receive incoming adverse event information from investigators and their reporting sites• Interact with study coordinators and investigators in collecting regulatory and site activation documentation• Manage logistics of teleconferences and in-person meetings for Site Study Coordinators, Principal Investigators and Protocol Team members• Coordinate/communicate effectively with project managers, database developers and clinical sites regarding data flow and management• Interact with study coordinators and investigators in collecting safety data and resolving discrepancies• Create DSMB (Drug Safety Monitoring Board) reports for distribution• Review and route queries from Medical Monitor to sites• Review and route queries from Study Sponsor to sites• Review and route queries from Drug sponsor to sites• Create meeting agenda for the Annual Site Study Coordinator Meeting• Perform presentation for the Annual Site Study Coordinator Meeting• Coordinate speakers, awards, and presentations for the Annual Site Study Coordinator Meeting

• Conduct and analyze medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries• Receive incoming adverse event information from investigators and their reporting sites• Track incoming reports• Determine initial/follow up status of incoming events• Perform full data entry of Serious Adverse Events in ARGUS safety database• Effectively maintain the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process• Perform consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions• Assist in tracking timelines for completion of AE processing• Route report information to appropriate Clinical Safety and Pharmacovigillance (CSPV) personnel for continued processing• Assist in generation of database queries for AE listings• Generate ad hoc line listings per non-routine requests from the safety data base.• Generate and/or QC aggregate reports• Assist in documentation of outgoing AE information, including:o Transmit/distribute safety reports to the internal Clinical/Regulatory teamso Distribute safety reports to the investigatorso Perform submission upload into EPIC documentumo Assist in tracking and confirmation of report destination

• Created configuration requirements to aid in building databases for clinical projects• Performed as an active member of the AERS)/Oracle Clinical (OC) solutions working group • Lead and assisted in developing SOPs for Regulatory and Oracle Clinical data functions• Developed work instructions and affiliated procedure forms• Performed Qualitative and Quantitative analysis on patient safety and behavioral data for Oncology and HIV/AIDS protocols• Worked as AERS/OC database liaison between the Regulatory and the Data Management department• Performed reconciliation of data between the AERS and OC databases.• Reported, reviewed, and data entered Serious Adverse Events (SAEs) received from clinical sites• Developed safety queries in response to incomplete/incorrect SAE reports• Maintained and operated various internal project databases (i.e. Site Information Management for Clinical Trials database, Regulatory Registration database, etc.)• Received, reviewed, and processed Protocol registration and Site Establishment documentation (ICF’s/ LOA’s/CM’s)• Interacted with study coordinators and clinical site investigators in collecting safety data and resolving discrepancies.• Directed communication with governmental/commercial clients • Collaborated effectively with project managers, CRAs, database developers and clinical sites regarding data flow and management• Assisted Senior Regulatory personnel with meeting planning, meeting conduct, and prepare meeting minutes• Contributed writing expertise to documents produced in the clinical trials area• Assisted in maintaining and forwarding safety documents• Assisted in maintaining and updating Trial Master File documentation• Generated protocol abstractions from government sponsored cancer trials• Analyzed and interpreted clinical data (CRF’s) submitted to the government clients to be forwarded to Cancer Cooperative Groups