Carmit Strauss
Executive Director, Head of Risk Management, Organ Toxicity and Benefit Risk
- Role
- Executive Director, Head of Risk Management and Organ Toxicity at Takeda
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
About Carmit Strauss
SUMMARY OF GLOBAL MEDICAL AFFAIRS AND MEDICAL SAFETY EXPERIENCE•Global medical affairs, clinical development and medical communications experience in Hematology, Oncology, Immunology, Lysosomal diseases, Pulmonology and Neurology•Medical safety and Pharmacovigilance experiance in hemotology, Lysosomal diseases and Pulmonology •Collaboration with key opinion leaders on strategic publications, development of a review paper, manuscripts and multiple abstracts and posters•Medical affairs lead for training and scientific communications supporting multiple product launches•Clinical studies: Protocol development, Statistical Analysis Plan(SAP) and Safety Review Reports •Develop and provide support for safety sections of clinical documents, including the review and approval of aggregate reports (DSUR, PSUR, PBRER) as well as CCDS, CCSI, final study reports, IB’s, RACT and other documents •Provide medical oversight of global pharmacovigilance activities of clinical trials and product development•Prepare/review aggregate safety reports for submission to regulatory authorities•Support various scientific meetings through competitive intelligence, key opinion leader engagements, literature analysis and scientific literature summaries•Develop and execute multiple internal and external educational scientific presentations and training programs•Organizing, planning and execution of round tables/focus groups and advisory boards •Organizing, planning and execution of non-CME Company sponsored symposiums• Work cross-functionally with legal and regulatory teams and provide medical consulting to ensure marketing and scientific materials are medically appropriate and accurate•Medical writing
Experience
Executive Director, Head of Risk Management and Organ Toxicity
May 2022 — Present · US
Education
University of Southern California, School of Pharmacy
Doctorate of Pharmacy, Pharnacy
University of California Los Angeles
Bachelors of Science: Microbiology Immunology and Molecular Genetics, Microbiology Immunology and Molecular Genetics
Skills
- Clinical Trials
- Medicine
- Pharmacovigilance
- Hematology
- Oncology
- Product Launch
- Biotechnology
- Immunology
- Clinical Research
- Clinical Development
- Pharmaceutical Industry
- Regulatory Affairs
- Pharmacy
- Neurology
- Medical Affairs
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