Patricia Steuwe
Britton,MI
Summary
Hardworking and motivated professional with over 10 years of experience and record of success in ICSR Management performing all aspects of case processing and management in pharmacovigilance. Experience with clinical trials for many varieties of cancer, dermatology, respiratory, neurology, cardiology, rare diseases and many more. Solid history balancing team performance, customer service targets and business objectives. Dedicated to working closely with employees to maximize productivity and optimize procedures. Decisive leader with good planning and organizational skills.
Overview
11
11
years of professional experience
Work History
PV Officer / ICSR Manager
Primevigilance
Cary, NC
11.2021 - 12.2023
- Provided guidance to team members on how to effectively complete tasks within established timelines.
- Supervised subordinate staff in carrying out daily duties and activities.
- Coached, mentored and trained team members in order to improve their job performance.
- Conducted quality, timely performance feedback and performance appraisals.
- Collaborated with other departments to ensure timely completion of projects.
- Delegated work to staff, setting priorities and goals.
- Provided leadership, insight and mentoring to newly hired employees.
- Reviewed completed work to verify consistency, quality and conformance.
- Interviewed prospective employees and provided input to HR on hiring decisions.
- Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
- Evaluated individual and team business performance and identified opportunities for improvement.
- Performed activities in the scope of Individual Case Safety Report (ICSR) management within agreed extent and timeframe (including, but not limited to): processing ICSR's in compliance with applicable regulations, performing follow up, SAR/SUSAR management, reconciliation, personal data protection, MedDRA/WHO coding, database reports and workflow management.
Sr. Safety Specialist
Syneos Health (inVentiv)
Raleigh, NC
03.2014 - 10.2021
- Prepared periodic safety update reports and other documents related to regulatory submissions.
- Assisted in post-marketing studies designed to assess long-term safety issues associated with drugs.
- Reviewed adverse event reports to ensure accuracy and completeness of data collected.
- Collaborated with medical directors, clinical research associates, and regulatory affairs personnel to ensure compliance with applicable regulations and guidelines.
- Drafted responses to inquiries from healthcare professionals regarding product safety information.
- Reviewed literature sources such as published scientific articles, abstracts, press releases and FDA public advisories related to drug safety topics.
- Contributed to the development of Standard Operating Procedures related to Pharmacovigilance activities.
- Maintained accurate records of drug safety data in accordance with regulatory requirements.
- Participated in internal audits of Drug Safety processes and procedures.
- Conducted periodic review of adverse event reports to assess accuracy and completeness of information.
- Evaluated pharmacovigilance data from multiple sources including spontaneous reports and clinical trial databases.
- Performed activities in the scope of Individual Case Safety Report (ICSR)
management within agreed extent and timeframe (including, but not
limited to): processing ICSR's in compliance with applicable regulations, performing follow up, SAR/SUSAR management, reconciliation, personal data protection, MedDRA/WHO coding, database reports and workflow management.
Clinical Research Coordinator
Toledo Community Oncology Program (TCOP)
Toledo, OH
03.2013 - 03.2014
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Monitored patient safety during clinical trials according to established guidelines.
- Reviewed CRFs for completeness and accuracy before database entry.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Kept patient care protocols and clinical trial operations in compliance.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collected, processed and delivered specimens from trial participants.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Developed case report forms for data collection at investigational sites.
- Assisted in preparation of informed consent forms for review by ethics committees.
- Conducted screening interviews to determine eligibility of possible subjects.
- Monitored subject enrollment and tracked dropout details.
- Gathered and reviewed study data.
- Placed orders for medications to be used in studies.
Education
Master of Science - Research Administration
Central Michigan University
Mount Pleasant, MI12-2018
Bachelor of Science - Health Administration
Eastern Michigan University
Ypsilanti, MI12-2013
Skills
- ARGUS
- Aris-G
- Obiee
- Medidata
- Rave
- MS Word, Excel, PowerPoint
- Narrative writing
- Workflow Management
- Client Relationship Development
- Good Clinical Practice
- Audit Assistance
- Regulatory Submission Support
- Quality Issue Identification
- Safety Compliance
- Adaptability and Flexibility
- Problem-Solving
- Effective Communication
- Multitasking
- Interpersonal Skills
- Corrective Action Implementation
- Data Entry
- Attention to Detail
- Written Communication
- Analytical Skills
- Team Collaboration
Timeline
PV Officer / ICSR Manager
Primevigilance
11.2021 - 12.2023
Sr. Safety Specialist
Syneos Health (inVentiv)
03.2014 - 10.2021
Clinical Research Coordinator
Toledo Community Oncology Program (TCOP)
03.2013 - 03.2014
Master of Science - Research Administration
Central Michigan University
Bachelor of Science - Health Administration
Eastern Michigan University
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