Vice President, Head of Drug Safety and Pharmacovigilance
Purdue Pharma is committed to advancing the medical care of patients with quality pharmaceutical products.
Drug Safety Physician with over 15 plus years in the pharmaceutical industry, who has experience in drug safety/pharmacovigilance, strategic PV & risk planning, clinical research, regulatory affairs, FDA & EMEA/MHRA/AFSSAPS interactions, ICH, compliance, training, risk management, drug safety crisis management & electronic data capture. During my tenure as a pharmaceutical physician, build safety organizations considered among the best in the industry, in addition to putting the necessary organization, procedures and system in place for ensuring compliance with global regulatory requirements and who has extensive experience managing important product safety issues from medical and regulatory perspective. Demonstrated success in providing expertise for regulatory, study design, protocol, standard operating procedures (SOPs), risk management (pharmacosurveillance), data analysis, and submissions of INDs, NDAs, ANDAs to the FDA for approval. Previous research experience in fields such as Pharmacology, Oncology, Neurology and Cardiology. Specialties • Drug Safety & Pharmacovigilance (Operations, Strategy & Planning) • Drug Safety Management Boards, Risk Management & Safety Crisis Management • Management Consultancy and Organization Excellence • Regulatory Affairs, Medical Affairs & Clinical Research • CRO, Medical & Regulatory Training • Drug Safety Outsourcing • Leadership Development • PV Audits and Mock Inspections • Compliance & Quality Management • Clinical Development
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