Cynthia L. Email and Phone Number

Safety Surveillance, Signal Analysis, Periodic Reports• Conducted daily and monthly reviews of clinical trial safety data, and regular literature review for 2 late-stage development oncology products. Identified and evaluated new safety signals as appropriate• Planned, executed, interpreted, and presented results for three comprehensive signal evaluation analyses for products in consultation with the Risk Management Lead (RML) and Global Product Safety Lead (GPSL)• Prepared and communicated findings from surveillance activities, safety assessments and othersources of safety data (e.g., Emerging safety issue, clinical trial SUSAR, product quality)• Supported the RML in responding to safety requests from regulatory authorities and internal functions (e.g., Clinical Trial Managers, Ethic Committees/ IRBs)• Prepared safety content and reviewed periodic aggregate safety reports (DSUR, 6-month line-listings)Study Documents• Contributed to review and analysis of safety content for protocols in development, protocol amendments, Clinical Study Reports, and reference safety information in other key study-related documents, e.g., IB, ICF, SMC/IDMC meeting materials• Developed and maintained Risk Profiles for development and comparative productsAdditional Contributions and Projects• Authored new business practice on creation, revision, implementation, and maintenance of targeted questionnaires• Mentored incoming PharmD fellows through weekly forums discussing foundational topics in PV/ drug safety (essential definitions, processes, guidelines/publications)• Managed preparation and logistics for weekly safety meetings, cross-functional GlobalSafety Team meetings discussing safety concerns and analytic plans• Represented SERM in Clinical Sub Team and Study teams and provided guidance on safety issuesOther Contributions and Projects

• Reviewed clinical trial and post-marketing safety data for assigned products on a routine basis• Supported the development and preparation of periodic aggregate safety reports (e.g., DSUR, PAER/PADER, PBRER)• Supported the development of Risk Management Plans (RMPs)• Reviewed safety content of clinical study protocols, study reports, informed consent forms, and Investigator’s Brochures • Contributed to regulatory submissions (e.g., BLA, supplemental applications) • Supported Risk Management Lead in responding to safety requests from regulatory authorities, affiliates, and other functions • Contributed to literature review, including assessment, interpretation, and preparation of results for inclusion into relevant safety documents

• Assisted students with literature searches and retrieving relevant articles using the school's available databases• Rented materials (textbooks, journals, and skills kits) to students in timely manner• Assisted patients in printing and copying services• Catalogued and maintained literature inventory• Ensured library environment was a safe space for students and staff and conducive to work

• Prepared, dispensed, and delivered medications, including controlled substances, for inpatients and outpatients• Charged patients’ medications• Redistributed returns and assisted in maintenance of inventory levels• Batched IV's and syringes as backup stock for new medication orders using aseptic technique

• Contributed to authoring of ad hoc safety reports for 2 oncology products by consolidating report drafts, conducting literature and datamining searches, and adjudicating for true cases of event(s) of interest• Contributed to preparation of PBRER and FDA information request• Presented evaluation of ADUHELM (aducanumab) in Alzheimer's Disease• Collaborated closely on cross-functional teams with Medical Safety Officers and Safety Analytic Scientists

• Recorded residents' meal orders and input them into point-of-sale system• Bussed and reset dining room for next service• Trained multiple new employees on workplace standards and procedures