Georges Bergen

Senior Manager, Global Safety Assurance @Reckitt

Essex County, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2020 — Present

Senior Manager, Global Safety Assurance @Reckitt

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Parsippany, NJ, US

Manage a global team of scientific professionals based in the US, UK, & India with responsibility for comprehensive regulatory & safety assessment of every unique Reckitt supplement launch, clinical trial, impurity / risk assessment, consumer adverse event, or quality-specific critical event procedure.Responsibilities:• Oversight of departmental safety evaluations as part of a launch process for every unique formulation across the global Reckitt business units (BU)• Establish safety for all human use clinical trials, including SOP method development, protocol standardization, and participant informed consent procedures• Contribute pivotal consumer safety declaration language to all product labeling or launches within the Health BU globally (e.g, allergen declarations and specific use instructions); • Manage impurity assessments, including California Proposition 65 risk assessments, as part of BU labeling & product launch procedures• Support innovation teams globally as they seek to develop new ingredients proposed for introduction into the Reckitt portfolio of nutritional products, including non-clinical safety testing, literature review, study design, and conduct of self-GRAS determinations• Work with GSA departmental leadership to set team-specific priorities, budgeting, & appropriate departmental metrics to track business deliverables• Manage personnel decisions & work with individuals to set & assess annual performance goals within the team• Delegate individual project management responsibilities across the team based on individual skill set & business needs• Engage leadership and teams across the BU to negotiate priorities and launch timelines• Comprehensive 3rd party portfolio due-diligence reviews as part of any M&A activity• Deliver regular updates and feedback specific to the BU for Sr. GSA departmental leadership, including the global Chief Safety Officer• Systems review & development of standard procedures across multiple facets of the BU

EDUCATION

2004 — 2006

Columbia University Mailman School of Public Health

MPH, Molecular Toxicology

SKILLS

R&DPharmaceutical IndustryFdaHplcProduct DevelopmentToxicologyAnalytical ChemistryFoodCross-Functional Team LeadershipIngredientsRegulatory AffairsLifesciencesChemistryCommercializationLife SciencesGmpFood Industry

ABOUT GEORGES BERGEN

Experienced Safety and Regulatory Affairs Manager with a demonstrated history of working…

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Georges Bergen — Senior Manager, Global Safety Assurance at Reckitt in Essex County, NJ, US | Unifers