Brendan Smyth
- Role
- Global Safety Officer (Gso) Neuroscience Specialty Care at Sanofi
- Location
- Omaha, NE, US
- LinkedIn followers
- 500 followers
About Brendan Smyth
Brendan J. Smyth, PhD, MD Brendan is a clinical pharmacologist, Phase I physician…
Experience
Global Safety Officer (Gso) Neuroscience Specialty Care
Aug 2021 — Present · Cambridge, MA, US
As a Global Safety Officer in Sanofi\'s Neuroscience Specialty Care division, I play a critical role in ensuring the safety our therapeutics. My responsibilities encompass leading pharmacovigilance and risk management efforts, collaborating with other GSO across indications for frexalimab, a key MS, SLE and Type 1 DM asset in our portfolio. I coordinate a multidisciplinary team of GSOs, ensuring alignment and excellence in safety practices across diverse therapeutic areas. In collaboration with the 3S (Systematic Safety Surveillance) initiative, I enhance safety management team meetings by developing advanced visualization graphics to streamline data interpretation and decision-making. My role involves integrating clinical judgment with proactive safety assessments, driving effective safety action plans, and engaging in signal detection to maintain compliance with global safety standards. As a key contributor to Sanofi’s commitment to patient safety, and \"play to win\" strategy, I ensure the timely and quality-driven preparation of regulatory submissions, periodic reports, and responses to health authority inquiries. By fostering cross-functional collaboration, I support the optimization of benefit-risk profiles and the implementation of innovative risk mitigation strategies. My work reflects Sanofi’s mission of advancing healthcare while prioritizing patient safety and well-being.
Skills
- Clinical Data Management
- Biotechnology
- Diabetes
- Clinical Monitoring
- Clinical Trials
- Edc
- Therapeutic Areas
- Pharmacology
- Ctms
- Medical Writing
- Pharmaceutical Industry
- Fda
- Drug Safety
- Ich-Gcp
- Pharmacokinetics
- Pharmacodynamics
- Medicine
- Clinical Development
- Neuroscience
- Genetics
- Biomarkers
- Regulatory Affairs
- Lifesciences
- Infectious Diseases
- Regulatory Submissions
- Clinical Operations
- Immunology
- Pharmacists
- Drug Development
- Nephrology
- Pharmacovigilance
- Psychiatry
- Gcp
- Biopharmaceuticals
- Cardiology
- Translational Medicine
- Clinical Study Design
- Pharmaceutics
- Drug Discovery
- Healthcare
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