Shavawn Morgan

Experience

1. Pharmaceutical Biotech CRO Global Medical Information & Drug Safety Consultant (3rd Party)

   Novavax

   Jun 2021 — Present

   Respond to global unsolicited Consumers (members of the public), Health Care Professionals (HCP) and other external Customer requests for Medical/Drug Safety information received via the Medical Information Call Center/Contact Center telephone lines, website, chatbots, e-mail and scientific meetings in various countries as part of Medical Affairs for product launch for the Covid-19 & variant vaccines (post-marketing surveillance) •Facilitate translation services for inquiries in various languages •Provide labeled and unlabeled medical/safety information responses in accordance with global regulatory requirements & industry standards such as the FDA, UK MHRA, Australian TGA, Health Canada, New Zealand Medicines and Medical Devices Safety Authority (Medsafe), HSA and World Health Organization (WHO) •Accurately identify, collect & write case report Adverse Events (AE), Pregnancy Reports, Special Situation Events and Product Complaint (PQC) clinical and post-marketing narratives in a clear and concise manner per global government regulations, Standard Operating Procedures (SOPs) and work practices/instructions in the global medical information IRMS database •Formulate and provide responses utilizing approved labeling & company standard responses, published literature and internal clinical & post-marketing surveillance data •Peer review case records (medical inquiries, potential adverse events and product complaints) to ensure quality and accuracy of response and appropriate case processing •Assist with writing custom responses utilizing this data •Escalate customer inquiries when needed •Perform follow-up with inquirers •Assist and/or perform literature evaluations including periodic safety updates, literature summaries and other medical writing projects as needed •Provide out of office (OOH)/after-hours coverage on a rotated basis (on call) with a global workforce utilizing Microsoft Teams •Create Adverse Event test data for Pharmacovigilance/Drug Safety team

Education

• Syracuse University

  MS in Neuroscience, College of Engineering & Computer Science, Syracuse, NY