V.P. - Global Therapeutic Area Safety Leader @ I am responsible for the brand safety strategy and for directly managing 18 Pharmacovigilance professionals in various countries and time zones. Currently, I am the Therapeutic Area Safety Leader for the Neurosciences Franchise. From May 2012 to Present (3 years 6 months) New JerseyHead of US Pharmacovigilance Organization at Novartis Pharmaceuticals Corp. @ Responsible for managing case processing teams and Medical Safety Function for the US Pharmaceutical Division. I directly manage 2 case processing team leaders, 2 project managers and 4 US Medics, with oversight for 32 personnel in the department. I interact with the FDA for ongoing and emergent issues. I am a main contact for EU and FDA safety on-site inspections. I have implemented processes to ensure the transition and oversight of outsourced case processing activities to off-shore sites. I've also led teams to develop effective SOPs to drive process changes to strengthen compliance with AE reporting from marketing and Specialty Pharmacy programs. From May 2009 to April 2012 (3 years) Head of US Medical Function @ Responsible for directly managing a team of 4 physicians to address local reporting issues for all US licensed products. Activities included REMS preparation, aggregate reporting, signal work-ups, product recall reviews, US Labeling reviews, participation in FDA nd EU inspections and case processing. From July 2007 to June 2009 (2 years) Global Medical Director (multiple products) and Brand Safety Leader (Tekturna) @ Responsible for all aspects of Worldwide safety for multiple products in the neuroscience, oncology and cardiovascular areas. Responsible for PSURs, Health Authority inquiries, signal detection, case processing, trial safety data analysis, IB updates and communication of safety issue to investigators. Responsible for safety sections of submission documents, Risk Management Plan and initial core labeling for the new entity, Tekturna. Led cross functional Safety Mangement Brand Teams and also organized and led KOL: meetings. From March 2004 to May 2007 (3 years 3 months) Medical Director, Drug Safety @ Responsible for Managing 4 team leaders across several therapeutic areas. Also managed Medical Physician Case Processing team. I was responsible for implementing new SOPs related to case processing, responding to Health Authority inquiries as well as for training newly hired physicians. I also participated in usual Medical safety physician activities such as aggregate reporting, case processing, investigator notification review, label updates, signaling and health authority inquiries. I assisted our IT staff in impleenting MedDRA updates and code mapping From March 2002 to May 2004 (2 years 3 months) Director then Co-Program Director of Residency Program, Director of Community Health Center. @ DIrectly managed residents in the hospital setting and residents and nurses in the Clinic setting. I practiced in-patient and office medicine about 65% of the time, and had teaching, management and research responsibilities the remaining time. From July 1994 to March 2002 (7 years 9 months)

MD, Medicine @ State University of New York Health Science Center at Brooklyn Todd Gruber is skilled in: Pharmacovigilance, Clinical Development, GCP, Clinical Trials, Pharmaceutical Industry, Therapeutic Areas, Oncology, Clinical Research, FDA, MedDRA, EDC, CTMS, Endocrinology, Infectious Diseases, Drug Development, Pharmaceutics, Market Access, Drug Discovery, Sop, Neurology, Pharmacology, Vaccines, Regulatory Affairs, Diabetes, IND, Medical Affairs, Drug Safety, Medical Writing, Medicine, Biostatistics, Immunology, Neuroscience, Dermatology, CRO, Cardiology, Biopharmaceuticals, Lifesciences, Regulatory Submissions