• Identified, validated and worked-up safety issues from signal detection activities and presented to SMT• Worked closely with Global Safety Physicians to review AE/SAE line listings for trends and safety topics• Participated in serious adverse event (SAE) reconciliation activities between Argus and EDC clinical trial database• Performed periodic Global Safety Database searches to support inquiries from stakeholders as required• Assisted PV operations in ICSR quality oversight and in working with QA to maintain high PV inspection readiness across all regions, and supported REMS and RMP activities• Utilized Standard MedDRA Queries (SMQ) to identify data for AESIs and safety topics of class effect• Contributed to activities in the monitoring of compliance with regulations and development of internal SOPs related to PV function• Participated in audits and related activities, and prepared responses to audit findings • Performed authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians• Assisted in the creation of ad hoc safety reports for submission to relevant stakeholders both inside and external• Reviewed all cases for completeness and accuracy of data versus available source documents

• Reviewed and provided PV therapeutic area input for the development of protocols, IBs, SAPs, CSRs • Carried out routine PV activities including ongoing signal detection and risk management by conducting an aggregate review of Adverse Events (AE), Serious Adverse Events(SAE) from clinical trials• Provided therapeutic area PV support and representation for modern developmental products in close collaboration with PV, clinical, regulatory, data management, and biostatistics• Supported activities such as signaling, safety data analysis for ad hoc queries, regulatory submissions including NDA, MAA, and aggregate report• Contributed towards RMP updates and REMS reports as appropriate• Participated in safety CRF development, safety monitoring plan, support of DSMB activities, and coding review• Updated SOPs and work instructions regarding signaling, ad hoc, and risk management reports as applicable• Prepared aggregate safety reports (DSURs, PADERs, PBRERs), including safety database, and quality checks• Assisted with Safety Physician and clinical representatives and coordinated the Reference Safety Information (RSI) for multiple development products• Demonstrated knowledge and stayed current to ensure compliance with current and applicable global PV regulations and guidelines (CIOMS, EMA, FDA, ICH)

• Collected, processed, documented, reported, and followed up on all serious adverse events (SAE) from clinical trials and all adverse events from patient-reported programs, post-marketing studies, registries, and all spontaneous reports• Transcribed, translated, and entered data from all serious adverse effects from clinical trials and all adverse events.• Interacted and exchanged relevant safety information with other departments and other functional groups within the company• Recorded and tracked receipts, submission, and distribution of serious adverse events, investigator notifications, periodic safety reports, and development safety update reports (DSUR) in cooperation with other departments

• Assessed customer needs, mitigate risk, and resolved issues; maintained confidentiality in compliance with HIPAA• Assist in preparation of units, patient rooms and beds for receiving patient admissions, returning surgical patients, transfers, emergencies or discharges • Communicates with patients, families, physicians, and unit personnel and peers in an accurate, courteous, and professional manner• Performs routine treatment procedures including enemas, applications of appliances for heat and cold and sitz baths• Provides direct patient care as delegated by RN staff • Reports changes in patient’s status to the RN

• Maintained strict adherence to HIPAA at all times• Assists the RN in minor procedures• Obtain and record daily weights• Monitor and records vital signs• Updates assigned bed status