Assoc Dir, Drug Safety

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.Under general direction leads assigned drug safety staff for compliance with adverse event reporting and risk management requirements for enhancing patient safety in use of the Companys products worldwide. Responsible for direction for processing of adverse event data in accordance with applicable regulations and standard operating procedures. Keeps management informed of important safety issues for assigned products and formulates and directs and implements plans to address signal detection and risk management needs. Serves as liaison with other departments as necessary. Responsible for formulation of procedures and policy, training and assessment of quality and compliance. Supervises assigned staff for performance of all functions, evaluates and monitors performance and career development. Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws. Under general direction leads drug safety staff for compliance with adverse event reporting and risk management requirements for enhancing safety in use of the Companys products worldwide Formulates and implements plans to address signal detection and risk management needs for assigned products Responsible for formulation of procedures and policy, training and assessment of quality and compliance Finalizes adverse event content of NDA periodic adverse event reports for submission to FDA Performs quality assurance and medical review of individual adverse events Keeps up to date with regulatory requirements and guidelines in the area of adverse event management, risk management. Remains current with necessary medical, pharmaceutical and clinical knowledge. Conducts medical analysis of adverse event data, safety assessments, signal detection, and prepares risk management plans. Performs related duties as assigned.QualificationsA minimum of eight (8) years of related experience, two (2) of which must be in a manager/ supervisory capacity; or, an equivalent combination of education and/or experience. Prior drug safety management experience, preferred.Required Knowledge and Skills: Knowledge of: " Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements for pharmacovigilance, risk management and related areas." Pharmacovigilance principles, practices and their application." Medical terminology and treatment modalities." Medicine and pharmacology principles, theory and their application." Computer systems and database and software applications, including Microsoft Office." Public speaking and presentation techniques." Current Company policies and procedures, including safety rules and regulations." English usage, spelling, grammar and punctuation. Skill in:" Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources." Analyzing problems, identifying alternative solutions, project consequences of proposed actions and implementing recommendations that support department goals and objectives." Interpreting and applying medical information, instructions, policies and procedures and guidelines pertaining to drug safety." Preparing clear and concise reports for adverse events." Ensuring compliance with all Company policies and procedures, including safety rules and regulations." Communicating clearly and concisely, both orally and in writing" Managing and organizing multiple projects and assignments.As part of Watson's mission, we dedicate ourselves to providing a respectful and rewarding work environment which includes competitive compensation and benefits.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.