Charlene Phillips Email & Phone Number

Bothell, Washington, United States

Direct and oversee case management activities performed internally and externally by vendors to ensure compliance with regulatory requirements, corporate and departmental procedures, and applicable Pharmacovigilance agreements.Monitor metrics for current and projected case management workload for internal case processing team and vendors.Provide subject matter expertise in the interpretation of regulations as it relates to ICSR processing and reporting.Develop and implement case management governing documents to ensure alignment with regulatory requirements and operational efficiency.Provide proactive leadership in the oversight of case management activities performed by vendors including training, quality evaluation, and issue management. Collaborate cross-functionally with Safety Evaluations and Risk Management, Safety Systems team, Safety Compliance, QPPV, Local Safety Officers, Clinical Operations, Regulatory Affairs and Product Quality regarding safety data collection, thorough analysis and comprehensive reporting.Manage and oversee literature surveillance avtivities and reconciliation activities involving the clinical database, vendors and business partners.Represent the Case Management team in operational meetings with business partners and vendors.Participate in and provide support during internal audits, business partner audits and Health Authority Inspections. Effectively lead the Case Management staff, fostering mentorship, conducting targeted training, implementing effective performance management and creating opportunities for sustained professional growth.

Boston, Massachusetts, United States

Expertly managed end-to-end Individual Case Safety Report (ICSR) processing maintaining compliance with global regulatory requirements.Effectively provided comprehensive training, mentorship and clear work direction to junior level staff.Supported and contributed to the development and implementation of case management governing documents.Collaborated with other Alexion departments and vendors to ensure accurate data collection, analysis and reporting in Alexion interventional trials, non-interventional trials and investigator-initiated trials / investigator sponsored research was compliant with global regulatory requirements and Alexion SOPs.Collaborated with vendors and clinical teams to ensure design of all clinical trials enabled timely processing and global regulatory compliance for all reportable safety events from assigned protocols.Collaborated with Clinical Operations, Data Management and Study Teams in the development of the safety related data collection forms and participated in reconciliation activities for assigned studies.Contributed significantly to the continuous process improvement efforts and standardization of pharmacovigilance processes and methods.Provided support during Health Authority Inspections and internal audit activities.

Morrisville, North Carolina, United States

Principal Safety Specialist (2020-2021)Senior Safety Specialist (2017-2020)Safety Specialist (2014-2017)Responsible for coordinating and performing adverse event (SAE/AE) triage and data entry into the Argus safety database, including coding of adverse event terms and writing comprehensive case narratives in accordance with client conventions. Performed quality review of cases to ensure consistency and accuracy of data.Actively participated in continuous process improvement efforts, driving efficiency and compliance.Served as the program lead and subject matter expert (SME) for case processing and regulatory submission activities in the Argus safety database and effectively communicated with the PPD leadership team and client contacts.

Raleigh, North Carolina, United States

Served as a proactive and organized charge nurse of a fifty-bed mother/baby unit, overseeing operations with meticulous attention to patient safety and quality of care.Expertly provided nursing care for antepartum, postpartum and neonatal patients, ensuring compassionate and comprehensive support throughout their care journey.Educated and empowered new parents on newborn care practices, offering expert guidance in breastfeeding and bottle-feeding support, while also emphasizing infant safety and risk reduction to foster confidence in parenting skills. Collaborated with patients, physicians and co-workers to provide excellent medical care for general conditions and those specific to pregnancy.

Smithfield, North Carolina, United States

Collaborated interdepartmentally to develop and implement care plans for patients in labor, antepartum and postpartum patients, post-operative patients and the mother / baby couplet.Provided exceptional nursing care and effectively supported patients throughout the labor and delivery process, including antepartum care for patients requiring inpatient monitoring, preoperative and postoperative care for both scheduled and emergency cesarean sections, postpartum and neonatal care.Educated parents and provided resources regarding effective pain management, newborn care, infant safety and risk reduction, personal care and providing breastfeeding and/or bottle-feeding support.

Rochester, New York, United States

Functioned as the charge nurse in the Operating Room, overseeing staffing assignments and prioritizing surgical procedures, particularly during critical or emergency situations, to maintain optimal patient care and operational efficiency.Served as the perioperative nurse specializing in obstetrics, general surgery, and orthopedic procedures, responsible for assessing patient readiness for surgery, ensuring informed consent, providing emotional reassurance and ensuring patient safety during the perioperative period.Collaborated interdepartmentally to develop and implement comprehensive care plans for patients in labor, antepartum, postpartum, and post-operative phases, ensuring coordinated and effective care for both mothers and infants. Provided compassionate nursing care and comprehensive support throughout the labor and delivery process, including specialized care for antepartum patients requiring inpatient monitoring, management of preoperative and postoperative care for scheduled and emergency cesarean sections, and attentive postpartum and neonatal care.

Rochester, New York, United States

Functioned as the Operating Room charge nurse, overseeing staffing levels and prioritizing surgical procedures, particularly during urgent situations, to maintain efficient and safe operating room operations.Served as a perioperative nurse, conducting thorough presurgical assessments, ensuring patient comprehension and consent, and providing emotional support to enhance patient comfort and safety throughout the surgical process. Developed and implemented personalized care plans for postoperative orthopedic patients, ensuring tailored treatment and education to promote optimal recovery outcomes.

Bachelor Of Science (Bs), Health/Health Care Administration/Management

BS in Health Services Administration

Associate'S Degree, Registered Nursing/Registered Nurse

Associates degree in Nursing