Angele Kronholm
Pharmacoviligance
New Brighton,MN
Summary
Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
14
14
years of professional experience
4
4
years of post-secondary education
Work History
Pharmacovigilance Manager, Systems and Submissions
ProPharma Group
Saint Paul, MN
01.2015 - 09.2023
- On-boarded new employees with training and new hire documentation.
- Cross-trained existing employees to maximize team agility and performance.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground, creating team that works with each employee's strengths.
- Developed and maintained relationships with customers and regulatory authority contacts through account development and regulatory questions and collaboration.
- Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
- Implemented improvement initiatives and developed compliance testing program to monitor and identify gaps in new and existing practices.
- Assisted with internal and external audits to confirm compliance with applicable laws and regulations, answering any questions regarding regulatory submissions, adverse event reports, aggregate reports, and Argus Systems.
- Maintained up-to-date knowledge of current and emerging compliance regulations.
- Prepared and submitted regulatory filings in timely manner.
- Wrote and submitted aggregate reports including Periodic Adverse Drug Event Reports, signal detection reports, complex combination product reports, Psych reports.
- Collaborated across teams to provide president's report metrics accurately, troubleshoot report issues, and problem-solve in meetings between operations and Argus IT teams.
- Identified, investigated and documented compliance violations and recommended corrective measures.
- Assisted with IT program compliance testing for multiple computer applications.
- Researched and answered adverse event regulatory questions for multiple teams regarding health authorities for both marketed and clinical device, drug, dietary supplement, and combination products.
- Supported growth and problem-solved for company of 120 employees in St. Paul to 2500 employees worldwide.
- Achieved and maintained 99% compliance rate for adverse event reports.
Print Site Coordinator
Xerox
Golden Valley, MN
10.2009 - 12.2014
- Supervised, trained, and supported team of over ten employees to print 12 million impressions per year.
- Researched and identified new vendors and suppliers to obtain competitive pricing.
- Ordered, maintained, and tracked hundreds of different supplies for General Mills print, mail, and shipping areas.
- Created database that tracks 1000 jobs and 700,000 sheets of print jobs per month.
- Achieved 25% less printer downtime by collaborating with Xerox Printer technicians to learn to fix .5 million dollar laser printers.
- Collaborated with clients to plan complex print and finishing projects, and communicate these objectives with staff.
Education
Associate of Arts - Graphic Design
Dunwoody College of Technology
Minneapolis, MN 09.2008 - 05.2009
Bachelor of Arts - Art Education
Bethel University
Saint Paul, MN 09.2002 - 12.2005
Skills
Policies and procedures
Strategic planning
Staff Management
Business administration
Financial Management
Verbal and written communication
Operations management
Schedule optimization
Improvement initiatives
Business planning
Project Management
Key Performance Indicators
Argus Administration
Problem-solving
Regulatory Research
Timeline
Pharmacovigilance Manager, Systems and Submissions
ProPharma Group
01.2015 - 09.2023
Print Site Coordinator
Xerox
10.2009 - 12.2014
Associate of Arts - Graphic Design
Dunwoody College of Technology
09.2008 - 05.2009
Bachelor of Arts - Art Education
Bethel University
09.2002 - 12.2005