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
Adverse Event Reporting
Pharmacovigilance and Clinical Safety
Argus
Training and Development
FDA and ICH Guidelines
Quality Control and Assurance
MedDRA and WHODrug
Operations management
Strategic planning
Team leadership
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