Under general direction, provides data management and data analysis and trending of adverse event complaint data. In addition, provides back-up technical support and training to users of the Company’s drug safety software system utilized to manage all complaints and adverse drug reactions received by the Company regarding its products. Leads the supervised Drug Safety staff towards achieving Company and departmental goals.
• Carries out managerial responsibilities in accordance with the organization’s policies and procedures, and FDA or international pharmacovigilance regulations and guidances.
• Provides guidance in data management and analyzing and interpreting adverse event data.
• Provides back-up support to all users of ARGUS drug safety system in order to manage the global complaint handling process. Interfaces with various departments in providing users with necessary training and technical support.
• Shares responsibility for system administration and configuration for the ARGUS drug safety database. Interfaces with the Information Services department on a regular basis with regard to system administration.
• Ensures that the functionality of the ARGUS drug safety system is in line with current business needs and regulatory guidelines. Keeps abreast of current regulatory issues and technical information that may affect the ARGUS drug safety system.
• Responsible for providing training to Drug Safety staff relating to Drug Safety SOPs associated with data management and drug safety database operation.
• Ensures that training contents are updated with changes in Drug Safety SOPs associated with data management and drug safety database operation.
• Ensures that appropriate training documentation for Drug Safety SOPs associated with drug safety database operation is maintained in accordance with department and corporate policies.
• Oversees, participates in and approves the interviewing, hiring, training and performance evaluation of departmental employees as appropriate. Provides coaching and assistance to direct reports in areas of work assignment delegation, problem resolution, and disciplinary action as appropriate.
• Provides assistance in internal/external audit preparations.
• Interprets, applies, and reassesses Standard Operating Procedures of the department as the procedures apply to database as needed.
• Attends relevant educational seminars and conferences to keep updated on latest Drug Safety database related issues and also trains the appropriate Drug Safety personnel on the new/revised information learned as appropriate.
• Establishes individual and department priorities and deadlines and supports completion of duties and/or assignments from a database perspective.
• Performs related duties as assigned.
Qualifications
Six (6) years pharmaceutical/clinical experience, including one (1) year in a supervisory or management capacity. Also includes:
Knowledge of:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Pharmaceutical and pharmacovigilance principles, practices and their application especially as it applies to drug safety database and associated electronic software / functionality.
• Quality assurance principles.
• Personal computer hardware and software applications, such as word processing, database programs, ARGUS drug safety software, MedDRA.
• Business English usage, spelling, grammar and punctuation.
• Pertinent federal, state and local laws and regulations.
• Principles and practices of budget preparation and administration.
• Principles and practices of supervision and training.
• Recruiting, interviewing, and selecting applicants in accordance with established employment practices and methods.
• Current Company policies and procedures, including personnel and safety policies and procedures.
Skill in:
• Analyzing problems, identifying alternative solutions, project consequences of proposed actions and implementing recommendations that support department goals and objectives from a Drug Safety database / software / functionality perspective.
• Interpreting and applying information, instructions, policies and procedures and guidelines pertaining to data management and pharmacovigilance with an emphasis in drug safety database perspective.
• Managing, coordinating, delegating assignments and reviewing the work of assigned department personnel; recruiting, interviewing and selecting applicants in accordance with established employment practices and methods.
• Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Providing leadership, direction and guidance to Drug Safety Staff in terms of Drug Safety data management and database and associated software / functionality.
• Ensuring compliance with all Company policies and procedures, including safety rules and applicable FDA and international regulations and guidances.
• Establishing and maintaining effective working relationships with individuals contacted in the course of work.
• Communicating clearly and concisely, both orally and in writing.
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. values the benefits of diversity. EOE M/F/D/V
