Vilma Athias
Summary
Experienced motivated Senior Drug Safety Associate, driven to optimize processes and streamline operations for team efficiency. Decisive leader with an analytical and flexible approach to solving problems. Results-oriented with a great understanding of regulatory principles and pharmacovigilance best practices.
Overview
16
16
years of professional experience
Work History
Sr. Associate Patient Safety
UCB, INC
01.2015 - 01.2021
- Played a pivotal role in establishing and maintaining organizational compliance of 98% by efficiently managing pharmacovigilance (PV) activities and ensured PV data integrity.
- Contributed to development and execution of PV training, SOPs, work instructions and deviation management.
- Served as US PV liaison for market research organization, program vendors, global safety offices and regulatory organization.
- Effectively managed multiple competing PV priorities while maintaining focus on daily drug safety operations deliverables and ensured audit/inspection readiness.
- Monitored vendor service metrics and performance indicators to identify areas of deficiency and implemented remedy.
Sr. Associate PV Systems Center of Excellence
UCB Pharma
01.2012 - 01.2015
- Created solutions implement electronic platform for deviation/CAPA management in partnership with global safety teams.
- Processed 95% deviations and CAPAs within SOP timelines through effective communication and collaborations with global stakeholders.
- Authored and distributed monthly local and global compliance reports.
- Monitored, reviewed and tracked periodic global regulatory reports ensuring 98% compliance.
US PV Compliance Manager/ Drug Safety Specialist
UCB
02.2005 - 01.2010
- Established deviation process and cleared a 3 year backlog of over 300 deviations in less than 10 month.
- Played integral role in ICSR triage, data entry, regulatory submissions (IND, NDA & BLA).
- Trained outsource vendor on US drug safety/ pharmacovigilance procedures and activities.
- Co-created global case processing user guide.
Education
Bachelor of Science - Biology
City College of New York of The City University of New York, The
New York, NY08.1982
Skills
- Client Engagement
- Triaging
- Preparing reports
- Report Writing
- Data Entry
- Multiple Priorities Management
- Issue Resolution
- Spreadsheet Management
- Cross-Functional Teamwork
- Computer competencies
- Training and mentoring
- MS Office
- Filing and data archiving
Timeline
Sr. Associate Patient Safety
UCB, INC
01.2015 - 01.2021
Sr. Associate PV Systems Center of Excellence
UCB Pharma
01.2012 - 01.2015
US PV Compliance Manager/ Drug Safety Specialist
UCB
02.2005 - 01.2010
Bachelor of Science - Biology
City College of New York of The City University of New York, The
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