Associate Medical Director (Pharmacovigilance) @ PAREXEL
Clinical Research-MD @ Cleveland Clinic Florida
Senior Director Medical Safety with extensive experience in the medical and clinical research industry. Seven years in clinical practice as MD, Obstetrics and Gynecology and more than fifteen years clinical trials implementation and pharmacovigilance. Accomplishes milestones and company targets by facilitating cross-functional internal and external relationships. Strong ability to communicate with all levels of the organization. Highly
Senior Director Medical Safety with extensive experience in the medical and clinical research industry. Seven years in clinical practice as MD, Obstetrics and Gynecology and more than fifteen years clinical trials implementation and pharmacovigilance. Accomplishes milestones and company targets by facilitating cross-functional internal and external relationships. Strong ability to communicate with all levels of the organization. Highly dedicated and motivated individual with exceptional work ethics. Bilingual, English and Spanish both verbal and written, sensitive to diversity.
Specialties: Pharmacovigilance, Pain management , Women’s Health, Surgery, Diabetes, Neurology, Stroke/Stroke prevention, Oncology.
Senior Director Medical Safety @ United States Regional Head From December 2014 to Present (9 months) Medical Safety Director @ Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile, Provide medical review and edits to IND Annual Reports, EU/PBRERs-PSURs-DSURs, US/PADERs Provide medical review and edits of Development Risk Management Plans, EU/RMPs or US/REMS Provide medical oversight for CCDS/CCSI, label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings and medical safety evaluation on Safety Monitoring Committees Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Serve as the Global Lead including training, operational delivery, project communication and quality control From November 2013 to November 2014 (1 year 1 month) RTPMedical Director @ From April 2011 to November 2013 (2 years 8 months) US-NC- RTPAssociate Medical Director (Pharmacovigilance) @ From December 2009 to April 2011 (1 year 5 months) Drug Safety Physician @ From January 2008 to December 2009 (2 years) Director Project Management Phase 1 Unit @ From June 2007 to January 2008 (8 months) Project Manager-Oncology&CNS @ From 2005 to 2007 (2 years) Clinical Research-MD @ From 1997 to 2004 (7 years)
MD, Doctor of Medicine @ Universidad de Buenos Aires From 1982 to 1988 Rosa Piccirillo is skilled in: Pharmacovigilance, ICH-GCP, Global Management, Global Strategy, Cross-cultural Teams, Clinical Research, Team Leadership, Mentoring, Clinical Development, Clinical Trials, CRO, GCP, Drug Safety, Diabetes, Neurology, Oncology, Medical Writing, Pharmaceutical Industry, Regulatory Submissions, Medical Affairs, EDC, Clinical Monitoring, Infectious Diseases, Regulatory Affairs, Clinical Data Management, MedDRA, Drug Development
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