Cassandra Miller RN, BSN
Broomall
Summary
Registered Nurse (RN), experienced with pharmacovigilance processes and ensuring drug safety through rigorous monitoring. Utilizes risk management strategies and safety signal detection to enhance patient outcomes and product safety. Knowledge of regulatory requirements and track record of maintaining compliance while collaborating effectively with cross-functional teams.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Specialist
Galderma
05.2023 - Current
- Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
- Oversee adverse event case reporting and conduct follow-up.
- Coordinate closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing studies (PMSR) and spontaneous reports.
- Evaluated incoming case reports for completeness, accuracy, and consistency before entering them into the global safety database (ARGUS).
- Streamlined pharmacovigilance processes by implementing new software and data analysis tools.
- Supported signal detection activities by conducting ongoing monitoring and analysis of safety data from various sources.
- Maintain a working knowledge of local and global company policies and procedures (SOPs)
- Exceeded inspection readiness targets through meticulous record-keeping and adherence to standard operating procedures (SOPs).
- Collaborate with contracted vendors, ensuring adherence to SDEA (Safety Data Exchange Agreement)
- Perform monthly reconciliation activities with vendors to ensure adequate oversight in reporting
- Assisted in the preparation of periodic safety update reports, ensuring timely submission to regulatory authorities. (FDA)
- Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
- Expanded knowledge base by attending industry conferences, workshops, and seminars related to pharmacovigilance best practices.
Client Account Manager - Adverse Event Line of Business
Ashfield Engage
05.2022 - 05.2023
- Built client relationships by responding to inquiries, identifying and assessing clients' needs, resolving problems, and following up with potential and existing clients.
- Developed comprehensive reports on account performance, presenting results to senior management during regular meetings. (Quarterly Business Reviews)
- Leveraged data-driven insights to optimize account performance and identify trends over time.
- Handled complaints, provided appropriate solutions, and alternatives within appropriate timeframes and followed up to achieve resolution.
- Established performance and service goals and held associates accountable for individual performance.
- Delegated tasks to existing support team members and used cloud-based tools to help solve complex business issues.
Licensed Call Center Supervisor
Ashfield Engage
11.2019 - 05.2022
- Monitored call quality and provided individual constructive feedback to enhance performance and address areas in need of improvement.
- Trained team members on performance metrics and consumer behavior identification.
- Developed process controls and metrics for daily management of call center.
- Enhanced team performance with consistent coaching, feedback, and development opportunities.
- Improved customer satisfaction by effectively resolving escalated issues and providing timely support.
- Collaborated with other departments for seamless coordination in addressing customer concerns, resulting in faster issue resolution.
Registered Nurse, Emergency Department
Riddle Hospital
08.2014 - 08.2019
- Demonstrated strong clinical reasoning skills when assessing patients' conditions, initiating appropriate interventions, and escalating concerns to physicians as needed.
- Collaborated with physicians to quickly assess patients and deliver appropriate treatment while managing rapidly changing conditions.
- Improved patient outcomes by consistently providing high-quality emergency care and implementing evidence-based nursing practices.
- Administered medications via oral, IV, and intramuscular injections and monitored responses.
- Collaborated with multidisciplinary healthcare teams to develop comprehensive care plans for patients presenting with diverse medical conditions in the Emergency Department.
- Acted as a resource for colleagues by sharing clinical expertise, participating in educational opportunities, and serving as a preceptor for new nurses joining the Emergency Department team.
Registered Nurse, Med-Surg/Oncology/PCU & ICU
Phoenixville Hospital
12.2012 - 08.2014
- Utilized critical thinking skills to prioritize nursing interventions based on patients'' acuity levels and individual needs.
- Conducted thorough patient assessments to identify changes in condition, promptly notifying physicians and initiating appropriate interventions when necessary.
- Administered medications safely according to established guidelines while closely monitoring for side effects or adverse reactions requiring intervention.
- Assisted in the training and mentorship of new nursing staff members, contributing to a positive work environment and high-quality patient care.
Education
MBA - Healthcare Administration
Texas Womans University
Remote05-2027
Bachelor of Science - Nursing
Millersville University
10.2019
Associates of Science - Nursing
Gloucester County College
Sewell, NJ05.2011
Skills
- Case processing
- FDA guidelines
- Post-marketing surveillance
- Adverse event reporting
- Drug safety monitoring
- MedDRA coding
- Pharmacovigilance regulations
- Time management
- Attention to detail
- Critical thinking
- Quality management systems
- Interdisciplinary collaboration
Certification
- Registered Nurse, PA State Board of Nursing
- Board Certified Emergency Nurse (BCEN)
- BLS, ACLS & PALS through American Heart Assoc.
Timeline
Pharmacovigilance Specialist
Galderma
05.2023 - Current
Client Account Manager - Adverse Event Line of Business
Ashfield Engage
05.2022 - 05.2023
Licensed Call Center Supervisor
Ashfield Engage
11.2019 - 05.2022
Registered Nurse, Emergency Department
Riddle Hospital
08.2014 - 08.2019
Registered Nurse, Med-Surg/Oncology/PCU & ICU
Phoenixville Hospital
12.2012 - 08.2014
Bachelor of Science - Nursing
Millersville University
Associates of Science - Nursing
Gloucester County College
MBA - Healthcare Administration
Texas Womans University
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