Vice President, Drug Safety

Job Description:CV Therapeutics, Inc. is engaged in the discovery and development of novel small molecule drugs for the treatment of chronic cardiovascular diseases. By applying the biomedical discipline of molecular cardiology to delineate mechanisms of cardiovascular disease, we are identifying new targets for drug discovery. Executive Director/Vice President Safety The Executive Director/Vice President, Drug Safety is responsible for the Safety and Pharmacovigilance function within the CV Therapeutics and will head CVT’s Safety Department. This individual will provide drug safety leadership within CVT and will ensure effective long-term planning and sound operational execution in support of commercial and development product safety. The primary mission of the department is to establish and maintain safety programs to support marketed and development products. The objective is to ensure effective postmarketing surveillance of the company’s currently marketed product, Ranexa. This individual will ensure effective review, reporting and follow-up of any adverse events or product complaints for CVT products. The incumbent will continue to refine the company’s safety philosophy and will oversee integration with regulatory, commercial and R&D functions. She/he will ensure that sound safety standards are maintained expanded as needed and that the function contributes to the strategic goals of the business. Objectives for this position include, but are not limited to: Developing an understanding of the company’s development programs and current commercial product and interfacing with colleagues to gain an in-depth knowledge of the current marketed product and pipeline projects and fully understand their attributes and complexities. Become familiar with current project plans and timetables including milestones and deadlines and comprehend how the safety function will provide effective contributions. Understanding current safety systems, processes and functions, and conducting an assessment to ascertain effectiveness. Oversee and ensure accomplishment of focused safety functions and safety operations. Promote communication and effective interface with internal groups (Regulatory Affairs, Clinical Development and Sales and Marketing) on safety and pharmacovigilance in terms of training, communication, integration and the identification of potential safety issues. Maintain an awareness of risk management within the company including activities to support proactive risk assessment, safety signal detection and risk minimization for marketed products and development programs. Provide leadership for the safety staff comprised of technical, professional and administrative employees. Determine the optimal organization structure to meet current programs and product objectives and effectively assign staff to support key activities and roles. Maintain knowledge of current and latest developments in cardiovascular research and other areas related to CVT products and pipeline.

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Job Experience:This position requires a minimum of 8-10 years experience in providing drug safety and pharmacovigilance support within the pharmaceutical industry, preferably with late stage, NDA and commercial product experience. An advanced degree is required; an MD with specialization in cardiovascular medicine preferred. Demonstrated ability to operate effectively and achieve results in a dynamic, matrix organization as part of a working team environment, with the ability to provide both strategic leadership on safety issues and tactical input regarding requirements is essential. This individual must be able to operate at a broad level to support business goals while overseeing execution of details, and possess a thorough knowledge of US and EU safety reporting regulations and guidelines. A history of forming effective working partnerships with colleagues, subordinates and external counterparts, as well as experience in supervising drug safety personnel, budgeting, organizing, and planning for a growing drug safety department supporting multiple products are critical. The ideal candidate for this position will demonstrate excellent organizational skills, the ability to work on multiple projects of varying complexity, and possess a proven track record of utilizing sound project management skills including setting goals and milestones and managing activities to meet these endpoints. This individual will be a proactive, high-integrity professional who utilizes sound judgment and applies this to operational decision-making, and is an effective communicator with strong verbal and written skills.CVT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan. To apply for this position, please go to https://www.cvt.apply2jobs.com .Equal Opportunity Employer.