David J. Wetzel
Pharmacovigilance Sr. Manager
Saint Paul,MN
Summary
Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.
Overview
13
13
years of professional experience
Work History
Sr. Manager Patient Safety Solutions
Fortrea
08.2021 - Current
- Lead and manage a cross-regional team of 9 case processors and quality control reviewers across the US, Canada, and South America within a clinical trial safety department.
- Ensure compliance with internal performance metrics by monitoring case processing timelines, quality standards, and overall efficiency.
- Oversee quality events and CAPA (Corrective and Preventive Action) initiatives, assisting in root cause analysis and implementing corrective measures to maintain regulatory compliance.
- Support team development and training, fostering growth and enhancing expertise to better respond to Sponsor requests and evolving study needs.
- Collaborate with global stakeholders to optimize case processing workflows and align safety operations with regulatory expectations.
Pharmacovigilance Line Manager - Contractor
IQVIA
05.2021 - 08.2021
- Managed safety operations staff in accordance with organizational policies and applicable regulations.
- Responsible for planning, assigning and directing work; performance appraisals and professional development guidance; rewarding and disciplining employees; addressing employee relations issues; resolving problems and absence management.
- Management of project resources assignments and assisting with staff training.
- Collaborate with other operations specialist's managers to address problem areas, work scheduling for current and projected projects, staffing needs, and projected peak workloads.
- Adapted quickly to changing industry trends, proactively identifying challenges, opportunities, and solutions for maintaining business success.
Pharmacovigilance Manager
ProPharma Group
02.2019 - 05.2021
- Enhanced organizational infrastructure to optimize operational efficiencies and develop a team of PV supervisors.
- Provided oversight and direction to a team of pharmacovigilance supervisors.
- Oversaw ICSR case management and delivered guidance and supervision to staff.
- Developed and implemented process improvements in the field of safety surveillance, SOPs, guidance documents, templates, and operational systems.
- Provided both internal and external support during PV audits.
- Managed and motivated employees to be productive and engaged in work.
Pharmacovigilance Supervisor
ProPharma Group
11.2017 - 02.2019
- Supported a variety of clients with diverse product profiles (drug, device, biologic) and developed detailed program specific Safety Management Plans, Working Practices, Work Instructions, and other documents.
- Provided oversight and direction to a team of 14 PV specialists.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
- Trained and mentored PV team members on program specific tasks (i.e., case assessment and processing) and provided a working knowledge of the program assigned.
- Acted as the primary point of contact for all drug safety processing related issues.
- Updated internal documentation to align with current regulatory and ICH guidelines.
Pharmacovigilance Senior Specialist
ProPharma Group
12.2016 - 11.2017
- Processed adverse event and complaint information per departmental SOPs.
- Composed medical narratives and performed full data entry of adverse events within Argus safety database.
- Utilized MedDRA and WHO drug dictionaries.
- Consulted with PV safety physician on complex medical cases.
- Reviewed and assessed complex medical records for adverse event reports.
- Actively obtained follow-up information for adverse event reports.
- Determined event and case-level seriousness and expectedness assessments.
- Determined ICSR and MDR regulatory reportability to FDA and other OUS territories.
- Performed in-line quality control measures to ensure reports were accurately submitted to regulatory authorities.
Pharmacovigilance Specialist
ProPharma Group
08.2016 - 12.2016
- Actively performed adverse event and complaint follow-up for pharmaceutical, DS/OTC, medical food, and medical device products.
- Composed medical narratives for ICSR report submission.
- Completed client notifications as required per departmental SOPs.
- Coordinated closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing spontaneous reports.
RN, Cardiovascular Intensive Care Unit
University of Minnesota Medical Center
02.2016 - 08.2016
- Cared for a complex patient population that were acutely ill and in critical condition.
- Continually obtained, assessed, prioritized, documented, and relayed new and pertinent data to various health care professionals.
- Coordinated with a team of healthcare professionals to ensure patients were provided optimal care.
- Maintained awareness of current developments and trends in nursing practice.
- Educated patients on disease management and self-care techniques, promoting lifestyle changes for improved health.
RN, ENT/Plastics/General Surgery Department
Mayo Clinic
03.2012 - 02.2016
- Served as a charge nurse and preceptor.
- Supervised direct patient care, performed patient assessments, and developed staffing assignments.
- Mentored new nursing staff, contributing to a supportive work environment and improved retention rates.
- Served as a liaison between physicians and patients'' families to facilitate clear communication regarding treatment options and progress updates.
- Managed complex cases of critically ill patients, ensuring optimal treatment plans were executed effectively.
Education
Bachelor of Science - Nursing
Edgewood College
Skills
ICSR and MDR case processing
Licensure And Certification
RN Licensure, Minnesota, R2063252, 06/30/23
Associations And Memberships
- Minnesota Chapter for Men in Nursing, 01/01/12, 12/31/16
- Drug Information Association, 06/01/19, Present
Timeline
Sr. Manager Patient Safety Solutions
Fortrea
08.2021 - Current
Pharmacovigilance Line Manager - Contractor
IQVIA
05.2021 - 08.2021
Pharmacovigilance Manager
ProPharma Group
02.2019 - 05.2021
Pharmacovigilance Supervisor
ProPharma Group
11.2017 - 02.2019
Pharmacovigilance Senior Specialist
ProPharma Group
12.2016 - 11.2017
Pharmacovigilance Specialist
ProPharma Group
08.2016 - 12.2016
RN, Cardiovascular Intensive Care Unit
University of Minnesota Medical Center
02.2016 - 08.2016
RN, ENT/Plastics/General Surgery Department
Mayo Clinic
03.2012 - 02.2016
Bachelor of Science - Nursing
Edgewood College
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