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Accomplished global pharmaceutical industry executive with diverse functional expertise across pharmacovigilance (PV), clinical development, medical affairs, global project management, and commercial strategy. Proven ability in patient safety to establish integrated risk management, PV operations, and PV compliance functions to support effective achievement of company development and commercial milestones.Demonstrated innovator across the PV sector. Recognized for translating regulatory requirements and technology to positive outcomes in patient safety. Successful track record across the globe in leading teams, co-development, co-marketing partnerships, and government relationships. Collaborative style with deliberate investment in colleague relationships to drive optimal results. Valued for mentoring and coaching talent to build exceptional teams while fostering effective people dynamics. Noted for promoting the growth of the field of drug safety and the career paths of individual safety professionals.
Independent
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Pharmaceutical ExecutiveIndependentPrinceton, Nj, Us
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Senior Vice President, Pharmacovigilance And Chief Safety OfficerMirati Therapeutics 2021 - 2024San Diego, California, UsProvided vision and leadership for Phase 1 to 3 studies, clinical and regulatory strategy, risk management, PV operations, and PV quality management for the global development, approval, and marketing of KRAZATI and subsequent molecules. Developed a formal safety function and long- and short-term strategies to support planned growth of this young company. Led the full transition of the Mirati safety function into BMS following the 2024 acquisition. -
Chief Safety OfficerCsl Behring 2017 - 2020Melbourne, Victoria, AuLed drug safety, PV operations, and quality assurance for the development of entire portfolio from FIH to approval and marketing at CSL Behring. Upgraded the company’s approach to safety and introduced state-of-the-art systems and benefit-risk assessment to ensure compliance with new regulations from FDA, EU, UK, and Asia, meeting long- and short-term company needs. Obtained superlative audit results from the Board of Directors stating the safety system was above industry standards. -
Chief Safety OfficerSanofi 2015 - 2017Paris, France, FrEstablished the global PV organization and headed all areas of drug, vaccine, and device safety. R&D leadership member with 450+ staff. Spearheaded transformation of the safety function to consolidate and align functions across a huge global footprint. Achieved commercial success as well as compliance requirements for both products in development and marketed including innovative molecules, biologicals, vaccines, devices, consumer health products, and generics. -
Vice President Medical SafetyBristol Myers Squibb 2011 - 2015Lawrence Township, Nj, UsDesigned and implemented safety risk management and operational protocols for multiple therapeutic areas. Built the PV infrastructure and practices needed to accelerate the development of breakthrough therapies in immuno-oncology, immunology, and rare disease. Advanced capabilities in risk management, signal detection, aggregate report writing, and safety science. Developed an evolved model for PV, partnering effectively with R&D to formulate strategic direction on complex medical issues, e.g., immuno-oncology early-stage safety signals and negotiated successfully with regulators. -
Vice President Safety StrategyPfizer 2008 - 2011New York, New York, UsNamed to a new role to transform the delivery of pharmacovigilance and risk management for ~600 products of an annual value of $14B in global markets. Executed multiple safety and regulatory document processes, including safety data analysis, providing deliverables for global markets. Integrated Safety Summaries, Benefit-Risk Assessments: Labeling Documents such as Clinical Overviews; Risk Management Documents such as REMS, RMPs; Regulatory Responses; Briefing Documents, and support to INDs, Core Data Sheets; and support to Investigator Brochures. Directed and participated in global regulatory inspections, audits, manufacturing quality issues, product complaints with associated safety issues, and product recalls.
Susan Welsh, Md Education Details
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Royal College Of Physicians, Faculty Of Pharmaceutical MedicineFellow Of The Faculty Of Pharmaceutical Medicine -
Harvard Business SchoolAdvanced Leadership Program
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University Of California, BerkeleyMaster Of Business Administration - Mba
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Washington University In St. LouisInformation Technology
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University Of LeedsMedicine & Surgery (Md Equivalent)
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University Of LeedsBachelor Of Science
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Farnborough HillChemistry
Frequently Asked Questions about Susan Welsh, Md
What company does Susan Welsh, Md work for?
Susan Welsh, Md works for Independent
What is Susan Welsh, Md's role at the current company?
Susan Welsh, Md's current role is Pharmaceutical Executive.
What is Susan Welsh, Md's email address?
Susan Welsh, Md's email address is we****@****ati.com
What schools did Susan Welsh, Md attend?
Susan Welsh, Md attended Royal College Of Physicians, Faculty Of Pharmaceutical Medicine, Harvard Business School, University Of California, Berkeley, Washington University In St. Louis, University Of Leeds, University Of Leeds, Farnborough Hill.
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