Feb 28, 2017
Brand Safety Leader Featured
Laredo , TX , United States Provides integrated safety input into all regulatory documents required during active development Review and provide integrated safety input into clinical study protocols and clinical study reports, including Brand Optimization studies Co-ordinate involvement of external experts (e.g. authors of white papers, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.) Prepare safety data for health authority review boards, respond to legal queries and CPO requests involving safety issues. Ensure safety information communicated to EU Qualified Person in a timely fashion. Manage Drug Safety Monitoring Board activities for assigned projects/products, as required, handle initial development and updates of safety information in Basic Prescribing Information (core global labeling),including addressing safety issues optimally in all project/product labeling claims. Manage responses from professionals on safety issues and Cycle Management, manage overall signal detection,monitoring,evaluation,interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. Develop and update, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management as relevant. Leads IPT Safety Subteam. Serves as safety representative on International Clinical Team (and IPT). Prepare and may present brand safety issues to internal Boards and other meetings. Provide relevant input for IPT, ICT and TA Expert Panel meetings, as needed Collaborate productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Provide support as needed for licensing activities, regulatory authority inspections and for project/product recall activities. Work and perform activities of Leader as needed. Job Requirements: Requirements: Post graduate degree in Pharmaceutical Medicine Master of Public Health in Epidemiology (or equivalent) Languages: Fluent in spoken and written English, Understanding in another language (e.g. French, German, Spanish) desirable. 3 years clinical experience postdoctoral 5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re-ports/submissions involving safety information. Experience in leading cross-functional, multi-cultural teams Experience with (safety or others) issue management Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications • EDUCATION: Medical Doctor , Medical degree required, Specialty Board certification desirable.
SuperJobsPlus Laredo, TX , United States