Michelle Kasprzak

Director, Global Pharmacovigilance & Patient Safety @Sobi - Swedish Orphan Biovitrum AB (publ)

Raleigh, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2021 — Present

Director, Global Pharmacovigilance & Patient Safety @Sobi - Swedish Orphan Biovitrum AB (publ)

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EDUCATION

N/A

East Carolina University

Life Science

N/A

The George Washington University

Master of Science in Health Science, Regulatory Affairs

N/A

North Carolina State University

Bachelor's degree, Zoology/Animal Sciences

SKILLS

AntiviralsMicrosoft OfficePharmaceutical IndustryFdaDrug SafetyCROMicrosoft WordAntinfectivesClinical ResearchGcpMedical WritingQuality ManagementPowerpointMicrosoft ExcelClinical MonitoringVaccinesSop AuthoringPharmacovigilanceCra

ABOUT MICHELLE KASPRZAK

WHAT I BRING TO THE TABLE“Dedication to projects and the ability to stay focused on timelines and quality deliverables.\" WHY I ENJOY WHAT I DO?“I enjoy the challenge of working with international colleagues to ensure alignment of processes and maintain compliance at the national and international levels. I also gain personal satisfaction from maintaining a strong pharmacovigilance system that supports patient safety.” HOW I BUILD SUCCESS“I have an appreciation for both local and international requirements, QMS compliance, and a willingness to embrace change as industry standards and best practices shift. Continued professional development, experience, and confidence in my knowledge and skills deliver trusted results.” WHY PEOPLE LIKE DOING BUSINESS WITH ME“I am fair, supportive, and actively engaged. I work well cross-functionally, assuming positive intent, and focus on developing strong working relationships with my peers. I seek collaborative support and clarity as needed to reach consensus.” MY PROUDEST MOMENTS“Establishment of a state-of-the-art pharmacovigilance system at Merz North America. When we were told we had an impressive safety system during numerous internal and external inspections (including two successful FDA inspections)-I am proud to know I was the one responsible for its initial implementation, management, and maintenance.” HOW I MEET DEADLINES“I am ALWAYS available and committed to my work. I participate in many early and late-night calls; overtime is at times essential to ensure the production of quality, timely deliverables.” HOW I MAKE A DIFFERENCE“I do things without being asked. I go the extra mile and make an impact on the business by going further, being more helpful, more supportive, and more valuable. I have a positive mindset and do not hesitate to take the lead. I empower myself and others.” HOW YOU CAN CONTACT MEEmail: m••••••••@att.net

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Michelle Kasprzak — Director, Global Pharmacovigilance & Patient Safety at Sobi - Swedish Orphan Biovitrum AB (publ) in Raleigh, NC, US | Unifers