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
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