• Provide pharmacovigilance functional area expertise and support on cross-functional project teams for developmental oncology products• Analyze individual case safety reports and aggregate safety data in conjunction with the Global Safety Lead to identify the risks and understand the safety profile of investigational products• Perform routine signal detection and evaluation in conjunction with the Global Safety Lead • Author relevant sections of aggregate safety reports (DSUR) and risk management plans• Review and contribute to the safety content of clinical trial protocols, investigator’s brochures, informed consent forms, and other relevant project/study documents• Coordinate and prepare safety analysis for cross-functional Safety Management Team meetings, performing routine safety assessments and addressing urgent safety issues • Perform ad hoc safety analysis and contribute to draft responses to regulatory authority queries• Participate in the review and evaluation of safety related reports from non-clinical sources to assess the implications for the safety and conduct of clinical trials • Participate and collaborate in the creation and review of Pharmacovigilance-related SOPs and other process-related documents

• Handle adverse events according to international regulatory requirements and per corporate SOPs• Liaise with third party vendor to ensure adverse events are handled according to internal and corporate partner SOPs • Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and marketed products, including decisions on seriousness, expectedness, and causality • Review literature articles to identify and escalate new safety information • Ensure accurate coding as per convention of adverse events from all sources• Author Similar Event Analysis reports following established procedures• Prepare responses to EMA Audits of third party vendor, identify necessary process changes, and train third party vendor in new procedures• Execute User Acceptance Testing scripts for PBRER and DSUR safety database performance • Contribute to the development of Data Handling Conventions and appendices• Collaborate with Medical Coding and Data Management to reconcile between the Clinical and Pharmacovigilance databases • Reconcile adverse events captured in Pharmacovigilance database from Product Complaints• Quality control review of clinical trial unblinding assignments in safety and clinical databases• Author deviation reports for cases submitted to regulatory authorities outside reporting window• Review cases and extract key info for data summary presented to Advisory Board• Keep management informed of special concerns and developing safety problems with investigational or marketed products

• Review and approve medication orders for adult patients on medical-surgical floors and ICUs• Identify issues with medication orders and collaborate with prescribers to optimize drug therapy• Provide drug information to prescribers, nurses and patients• Monitor drug therapy according to established department programs such as vancomycin pharmacokinetics, renal dosing, IV to PO interchange, warfarin dosing and interaction notification• Document pharmacy interventions including rationale for clinical decisions• Report medication errors and adverse drug reactions in appropriate hospital wide quality databases• Represent pharmacy on a multidisciplinary committee aimed at improving hospital wide HCAP scores. Instrumental in development of subcommittee program focused on improving HCAP scores relative to patients' knowledge about their medication• Verify the preparation of sterile products and unit doses prior to dispensing• Co-precept pharmacy students and PGY-1 pharmacy residents

• Provided informed consent review, master file review and document tracking services for the hemophilia program• Assisted team in preparation for master file audit• Edited and contributed to protocols, amendments and informed consent prototype documents

• Provided clinical, safety, data management, and medical writing services for bone marrow transplantation studies• Contributed to phase I/II oncology protocols, amendments, informed consents and Investigator Brochures• Collaborated with statistician and data management to write, track and facilitate resolution of data queries

• Served as Study Team Leader for phase I/II oncology study of a novel cytotoxic agent• Managed clinical trials in accordance with the GCP/ICH Guidelines• Conducted pre-study, initiation, closeout & routine monitoring visits• Co-authored and participated in the development of phase I/II oncology protocols, amendments and informed consents• Developed study budget and ensured appropriate payment of clinical sites• Trained clinical personnel to conduct studies in accordance with sponsor protocols, SOPs and GCP/ICH guidelines

• Determined drug supply needs and communicated with Clinical Supplies group to coordinate manufacture, packaging and distribution of clinical trial material for phase I/II oncology studies• Trained clinical personnel in SOPs related to drug accountability• Assisted in the development of patient enrollment procedures and study tools including tracking forms, patient diaries, and patient instructions for self-administration