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Job Title: Sr Director Drug Safety
Job Location: NY: New York
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-23

Company Name: MSI International
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: Mar 4 New York, NY Tarrytown, NY Sr Director Drug Safety MCA29114

Requirements Sr. Director, Drug Safety

This position will be responsible for providing strategic, managerial and medical leadership in the area of drug a safety and pharmacovigilance while maintaining compliance with corporate policies and regulatory requirements. A strong emphasis on leadership and management skills are needed to productively build the drug safety group, and lead it through the launch of our first product. This position will report to the Senior Vice President & Chief Medical Officer. ESSENTIAL JOB FUNCTIONS: -Works with the CMO to ensure the strategy and vision of the department is aligned and integrated with The Companys corporate goals -Responsible for the strategy and implementation of activities, and is ultimately responsible for the quality of work and its interpretation -Manage all aspects of drug safety surveillance, drug safety operations, and pharmacovigilance globally for investigational and marketed products -Manage risk management activities including the development of risk minimization action plans, safety strategies, the robustness of the processes and procedures used to collect adverse drug reactions, safety querying, and signal detection -Liaise with CROs as needed to ensure pharmacovigilance agreements and surveillance obligations continue to be met ADDITIONAL RESPONSIBILITIES/DUTIES: -Participates with other senior managers to establish strategic plans and objectives -Makes final decisions on administrative or operational matters and insures operations effective achievement of objectives -Manages in a matrix environment -Develops metrics to help set standards and assess performance of department -Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors Requirements . EDUCATION and/or EXPERIENCE: MD or PharmD required; MD strongly preferred. Broad medical background and clinical trial experience with both Small molecule and biological products desired. Candidate must have 8+ years of industry clinical safety experience in a biopharmaceutical company, with increasing responsibilities for managing safety/surveillance activities. Thorough knowledge of drug safety regulations and guidelines in the US and EU, particularly ICH clinical safety guidelines. Basic MedDRA training required. Experience with safety database management and computerized data analysis required. SKILLS and ABILITIES: -Strategic vision to support the development of the Drug Safety group -Strong line management and matrix management skills -Excellent verbal and written communication skills -Proven ability to lead projects and teams -Proven ability to hire and mentor direct reports

Please refer to Job code iinternational-29114 when responding to this ad.

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