Susie Szembek, BS

PHARMACOVIGILANCE, SAE REPORTING, MEDICAL CODING,
MONITORING
PERSONAL PROFILE
*20 years of global pharmacovigilance, safety protocols, medical coding, and database management.
EXPERTISE
Pharmacovigilance; Safety Protocols in Phase 1, 2, and 3 Clinical Trials; Database Management; AE/SAE Reporting and Narration Development; Coding Reviews; Reconciliation; Program Management; Physician Interaction; Marketing. Study Therapeutic Areas of Expertise: Oncology, Allergy, Pain, Diabetes, Cardiology, Cardiac Devices, Pruritus in Renal Disease, and Insomnia.
PROFESSIONAL EXPERIENCE
Medical Coder, eClinical Solutions
Appropriately coding adverse events, medical history, concomitant procedures, and concomitant medications using WHODrug and MedDRA dictionaries.
Drug Safety Consultant, Drug Safety Solutions, Inc.
Executes AE/SAE management activities including receiving and processing SAEs, maintaining safety database entries, site and reporter queries, safety database reconciliation, SAE narrative creation, and legacy coding. Coordinates and manages physician interactions.
Drug Safety Consultant, Accelovance
Executed AE/SAE management activities including receiving and processing SAEs; maintaining safety database entries; site and reporter queries; safety database reconciliation; narrative creation and medical history, SAE, and Con Meds Coding. Entered events into ClinPlus and generated MedWatch forms.
Drug Safety Consultant, Drug Safety Manager, CRMG
Managed treatment emergent and non-treatment emergent SAEs with Chief Medical Officer, reviewed all SAE reports for accuracy, and generated all MedWatch and CIOMS forms.
Drug Safety Specialist, Sunovion Pharmaceuticals (formerly Sepracor)
Managed and conducted consumer follow-up on all marketed products. Generated safety narratives, as needed.
Drug Safety Specialist, Clinical Research Associate, and Clinical Data Manager, PAREXEL
Reviewed laboratory and diagnostic findings for accuracy, seriousness criteria, and intensity; created SAE narratives and study protocols, and reviewed SAEs for project success; maintained spreadsheets; tracked events; and provided effective communications. Phase 2 and Phase 3 studies included obesity, reperfusion injury in lung transplant patients, diabetes, antiemesis, and otitis media.
Drug Safety Specialist/Senior Clinical Research Assistant, Muro Pharmaceuticals
Developed and reviewed SOPs for drug safety and assessments of global serious adverse events for clinical studies, created SAE narratives, prepared FDA inquiry responses to SAEs, completed MedWatch forms for post-drug marketing, prepared IND safety letters, established MedDRA coding conventions with German counterparts, coded serious adverse events including MedDRA, maintained safety databases, prepared Regulatory Affairs packets, and prepared aggregate case data for Periodic Safety Updates and IND annual reports. Presented at Investigator Meetings and performed project and team management services and cross-team interactions with Sales Team. Reviewed laboratory test results; completed CRF safety reviews; provided periodic educational review, as well as oral and written presentations of SAE reporting requirements for CRO staff; reviewed CRF design and Informed Consent Templates; and participated in end-of-study unbinding and reconciliation processes.
Senior Clinical Research Associate, Boston Scientific Corporation
Monitored for microvasive endoscopy, specifically to the Biliary and Gastrointestinal Tract Phases 3 and 4.