Christianne Parotti
Executive Director, Drug Safety and Pharmacovigilance @Eli Lilly and Company
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WORK HISTORY
Executive Director, Drug Safety and Pharmacovigilance @Eli Lilly and Company
Represent the Drug Safety and Pharmacovigilance (DSPV) function in cross-functional projects and study teams for the safe conduct of clinical trials, monitoring the safety profile of products, and contribute to their risk/benefit assessment.• Assist Clinical Scientists to develop medical monitoring strategies for clinical studies and clinical programs.• Support Global Patient Safety (GPS) in the evaluation and management of safety signals emerging from any data source, including signal detection, benefit-risk profile assessment and aggregate reporting activities.• Oversee, prepare, and/or review safety documents including scheduled periodic/annual safety reports, risk profile, signal evaluation reports, and other safety-related documents.• Contribute to and/or review relevant clinical study documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Statistical Analysis Plans (SAPs), clinical protocols, informed consent forms (ICFs), and IND/CTA submission documents, case report forms, medical monitoring and safety management plans (SMPs).• Formulate responses to Health Authority inquiries with information relevant to product safety.• Responsible for managing internal and external staff allocated to PV activities, including the mentoring of internal staff.• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of safety requirements in accordance with ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice (GVP).• Contribute to, draft, and implement department SOPs and work instructions related to the PV activities.• Ensure PV activities comply with inspection readiness expectations.• Partner with various functions within Lilly GPS and ensure safety activities conducted by GPS properly support DICE studies.• Responsible for a compliant and quality execution of all operational activities as described in PV agreements with Vendors and/or Lilly GPS
EDUCATION
Michigan State University
Masters, Pharmacology and Toxicology
Universidade Federal de Goiás
Bachelor of Pharmacy, Science, Pharmacy.
SKILLS
ABOUT CHRISTIANNE PAROTTI
I\'m a Pharmacist with over 20 years of experience in the pharmaceutical industry. I\'m passionate about patient safety, process improvement, innovation and science.
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