Nicole Stein
Warrington,PA
Summary
Registered nurse with over 15 years of expertise in pharmacovigilance and patient care, recognized for exceptional mentoring abilities and a steadfast commitment to operational excellence. Proven success in leading projects that enhance product safety and compliance, along with a strong track record of improving health outcomes through meticulous risk management and quality control. Highly motivated and resourceful, adept at adapting to diverse processes while driving company objectives and enhancing business performance. Strong planning, organizational, and time management skills facilitate effective handling of multiple priorities in fast-paced environments, fostering robust relationships with stakeholders at all organizational levels.
Overview
19
19
years of professional experience
Work History
Register Nurse
Bayada Home Health Agency
03.2025 - Current
- Provides skilled nursing care to adult patients in their home.
- Documents assessments on cubhub application.
- Adult skilled homehealth care agency.
SAFETY REPORTING SPECIALIST
PPD/Thermo fisher Scientific
08.2022 - 06.2024
- Receive, prepare and submit safety reports to applicable parties.
- Lead in small and medium projects and escalates with the line manager if any issues are encountered.
- Provide project status, metrics, issues etc. with Internal Study Team and Internal Management as needed.
- Ensure reports were submitted in compliance with regulatory timelines and country legislation.
- Collaborate with cross-functional teams to ensure compliance with internal and external standards for safety reporting and liaise with various departments around safety reporting tasks and the setting up of client accounts.
- Prepare, attend, and present in project teams meetings as needed.
- Provide training and support to other team members.
- Perform administrative tasks such as filing and the maintenance of safety reporting systems and information.
- Participate in audits where required and perform testing activities as needed.
- Monitor safety reporting activities during the course of a study ensuring timely submission of adverse events.
- Review safety data from clinical trials and marketed products for accuracy prior to submission.
- Analyze and interpret regulatory requirements for product registration in various countries.
- Implement effective processes to track changes in local or global regulations.
- Maintain up-to-date knowledge of relevant industry standards and best practices.
- Compile and maintain regulatory documentation databases and systems.
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Assist with the preparation of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required by the company.
- Global provider of clinical development and laboratory services, focused on operational excellence. Improves patients’ health by helping customers deliver life-changing medicines.
SAFETY SPECIALIST
PPD/Thermo Fisher Scientific
10.2019 - 08.2022
- Process Serious Adverse Event which includes review, safety database entry, tracking, narrative writing, requesting follow-up from site and reporting to client (s) or agencies for assigned projects.
- Review incoming Serious Adverse Event data for completeness and accuracy.
- Adhere to corporate policies, Standard Operating Procedures, and awareness of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines and other relevant global and local regulations.
- Effectively interfaced with Project Teams, Client Companies, and Investigators regarding Serious Adverse Event activities.
- General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs.
- Performed literature reviews for safety reporting program and regulatory requirements.
- Maintained basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope.
- Maintained knowledge and understanding of safety related regulations and guidelines.
- Attended internal and client meetings as appropriate.
- Support the coordination of several therapeutic areas with acute focus on alignment and expansion of service offerings.
- Identify and participate in process improvement initiatives to meet timelines for projects.
- Maintain effective communication with internal stakeholders on pharmacovigilance matters.
- Provide training to new team members on pharmacovigilance policies and procedures.
- Generate queries for missing or unclear information and follow-up with sites for resolution through RAVE. Medidata, and oracle.
- Ensure the timely and accurate completion of case processing due diligence activities.
Endpoint Adjudication Specialist
ICON Clinical Research
03.2012 - 06.2019
- Prepared and conducted review of clinical endpoints and adverse events covering different therapeutic areas in the medical field.
- Performed quality assurance, reconciliation and study close out activities.
- Ensured timely collection of documents and components of adjudication packages for clinical endpoint committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials.
- Collected, quality checked, and ensured that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them.
- Blinded project specific clinical data from source documents per protocol.
- Maintained knowledge of good clinical practices (GCP), federal regulations, international standards, and company SOPs.
- Processed queries from physician adjudicators, clinical site personnel, and company personnel as it related to collection of dossier components.
- Attended and participated at investigator meetings, team meetings and weekly sponsor meetings.
- Assisted in developing charter and procedure documents.
- Trained new hires on processes, protocols, and procedures.
- Reviewed participants hospital and clinic charts, computer records, microfilm; records information transferring appropriate information or data to a coding document.
- Utilized: Oracle, Inform, Medidata, MIRA, PACE, JUDI, Outlook, WORD, and Excel databases.
- Reading, understanding and adhering to organizational Standard Operating Procedures (SOP).
- Established and enforced departmental standards.
- Reviewed and updated company SOPs.
- Created and reviewed documentation including imaging manuals, charters, study specific rules, etc.
- Reviewed and engaged with clients by providing regulatory input for protocol, charters and data.
- Reviewed participants' hospital and clinic charts, computer records, microfilm and records.
- Global provider of outsourced drug development and commercialization services (CRO).
Drug Safety Associate
Alliance Healthcare Information
03.2010 - 03.2012
- Processed Serious and Non-Serious Adverse Events as reported in clinical trials and post-marketing sources and provided quality documentation.
- Received, interpreted, and processed Initial or Follow-up Serious Adverse Events (SAE) Reports, pregnancy reports and medical records.
- Interpreted and classified the sources of adverse events.
- Assessed case reports for seriousness, case validation, causality and listedness.
- Coded events, followed by data entry (Argus Database), and prepared written summaries for pharmaceutical clients.
- Provides outsourced medical services in the pharmaceutical, biotechnology and medical device industry.
Registered Nurse
Always Best Care Senior Services
01.2010 - 01.2012
- Applied effective communication techniques when interacting with patients and families.
- Maintained accurate records for each patient encounter according to established standards.
- Utilized critical thinking skills to assess patients' needs and develop individualized plans of care.
- Exercised sound judgment when making decisions regarding patient safety and well-being.
- Assessed and evaluated patient physical, mental, and emotional status to assist with care needs.
- Demonstrated knowledge of medical terminology, anatomy and physiology in the delivery of nursing care.
- Collaborated with the interdisciplinary team on patient care plans.
- Collected and recorded patient-related data through the performance of direct care tasks.
- Provides in-home care for seniors to maintain a safe and healthy lifestyle.
Healthcare Communicator
Alliance Healthcare Information
01.2010 - 12.2010
- Recognized adverse events and product quality complaints for pharmaceutical clients.
- Responded to medical information inquiries from healthcare professionals and the public on various products.
- Recognized and completed first line documentation of product quality complaints and Adverse Events.
- Triaged a high volume of phone calls directly from patients.
- Identified adverse event and product quality daily.
- Liaised with Pharmaceutical Marketing teams to understand promotional claims for products in line within federal guidelines.
- Maintained excellent quality and productivity standards for the client by adhering to program scripts and guidelines.
Registered Nurse
Abington Memorial Hospital
08.2009 - 04.2010
- Provided skilled nursing care to rehabilitation and medical-surgical patients.
- Identified opportunities for improvement within the unit's processes and systems.
- Compared patient response with observable outcomes to evaluate effectiveness of care.
- Developed and implemented teaching plans for patients and families regarding disease prevention, treatment options and management strategies.
- Obtained specimens to run monitoring or diagnostic tests.
- Prepared patients for examinations, operations, and treatments and assisted during procedures.
- Liaised with multidisciplinary teams to organize and coordinate health and care services to meet patients' complex care needs.
- Participated in multidisciplinary rounds to discuss the current plan of care for each assigned patient.
- Prioritized workloads based on changing clinical situations.
- Determined learning needs of patients and families to develop appropriate teaching strategies.
Travel Registered Nurse
Cape Coral Hospital
01.2009 - 04.2009
- Provided direct nursing care to acutely ill patients, including medication administration, wound care, IV therapy management, and other medical treatments.
- Used competent clinical practice and critical thinking skills to efficiently deliver patient care.
- Responded to medical emergencies, alerting appropriate team members.
- Maintained a clean and organized work environment, including patient rooms and nursing stations.
- Adapted to diverse patient populations and healthcare settings, demonstrating flexibility and cultural sensitivity.
- Administered prescribed medications as ordered by physicians and maintained detailed documentation of administered drugs and controlled substances per established policies and procedures.
- Utilized advanced nursing skills and techniques, including wound care, IV therapy, and medication management, to provide high-quality patient care.
- Managed and maintained relationships with patients, families, and healthcare providers, ensuring effective communication and collaboration.
- Used computers to complete necessary patient charts and documentation on patients' progress.
Registered Nurse
Pennsylvania Hospital
06.2006 - 09.2008
- Provided skilled nursing care to pre- and post-operative patients on orthopedic, neurosurgical, and medical-surgical floors.
- Utilized critical thinking skills to assess changes in patient conditions, recognize complications and intervene appropriately.
- Managed multiple tasks while providing timely, high quality patient care.
- Monitored vital signs as part of ongoing assessment process.
- Responded to life-saving situations based upon nursing standards and protocols.
- Protected patients' rights and dignity by delivering care without judgment or discrimination.
- Assessed patient needs through physical assessments, interviews and observation techniques.
- Educated patient and family members on symptom management and supportive treatments to improve continuity of care.
- Reported symptoms, condition changes and vital signs to primary care doctors, patients, and families.
- Documented patient assessment findings and responses to nursing intervention to progress toward problem resolution.
- Maintained confidentiality in patient matters to comply with HIPAA guidelines and measures.
- Delivered non-judgmental and non-discriminatory care sensitive to patient diversity, preserving dignity and rights.
- Coordinated discharge planning activities for patients transitioning from acute care setting to home care or other post-acute settings.
Education
B.S. - Nursing
Temple University
12.2008
A.D. - Nursing
Bucks County Community College
05.2006
Skills
- Strategic Thinking
- Attention to Details
- Decision Making
- Works Independently
- Solutions & Problem Resolution
- Good Clinical Practice Knowledge
- Regulatory Compliance Knowledge
- Budget Management
- Microsoft Software (Word, Excel, PowerPoint, etc) Proficient
- Organization of Multiple Task
- Medical and Scientific Terminology Knowledge
- Clinical Assessment
- Adverse Drug Events of International Regulations and of Reporting Requirements
- Computer Technology
- Management of Relational Database Systems
- Extraction of Data
- Positive Attitude
- Organization Skills
- Reconciliation
- Argus
- Medra
- Expedited Reporting
- Exemplary Clinical Documentation
- Self Starter
- Quiet and Secure Office Space
- Medical terminology
Professional Licensure
Registered Nurse Licensure, Pennsylvania, 2006
Personal Information
Title: Registered Nurse
Timeline
Register Nurse
Bayada Home Health Agency
03.2025 - Current
SAFETY REPORTING SPECIALIST
PPD/Thermo fisher Scientific
08.2022 - 06.2024
SAFETY SPECIALIST
PPD/Thermo Fisher Scientific
10.2019 - 08.2022
Endpoint Adjudication Specialist
ICON Clinical Research
03.2012 - 06.2019
Drug Safety Associate
Alliance Healthcare Information
03.2010 - 03.2012
Registered Nurse
Always Best Care Senior Services
01.2010 - 01.2012
Healthcare Communicator
Alliance Healthcare Information
01.2010 - 12.2010
Registered Nurse
Abington Memorial Hospital
08.2009 - 04.2010
Travel Registered Nurse
Cape Coral Hospital
01.2009 - 04.2009
Registered Nurse
Pennsylvania Hospital
06.2006 - 09.2008
A.D. - Nursing
Bucks County Community College
B.S. - Nursing
Temple University