Manager, Pharmacovigilance Operations - (Job Number: 0804320)

Manager, Pharmacovigilance Operations - (Job Number: 0804320) DescriptionCentocor Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Pharmacovigilance Operations, located in Chesterbrook, PA. Centocor, Inc. develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Under the direction of the Sr. Director, PV Operations, this position will be responsible for the management of pharmacovigilance operational activities for Centocor products. Supports other functional areas with regards to Pharmacovigilance (PV). Assists in efforts for establishing process and guidelines, departmental decision-making and resource assessments. Will manage direct reports, providing leadership, mentoring and coaching to ensure the highest level of quality and compliance is obtained while performing PV activities. Oversees the work and professional development of these direct reports, managing adherence to PV goals and objectives. Perform administrative tasks associated with performance reviews, salary administration, staff recruitment, and other personnel issues. Participate in departmental strategic planning and management, including but not limited to the development and implementation of departmental objectives and management of departmental budget. Identify and communicate any deviations, problems, or issues requiring changes to PV resource assignments or established timelines and objectives. Manage PV projects and activities, as assigned, including: Clinical R&D activities to ensure compliance with applicable regulatory requirements (PV), J&J Pharma requirements and/or Centocor procedural documents. Management oversight of adverse event regulatory reporting and operational activities. Cross-functional, cross-pharma process improvement initiatives. Collaborate and develop partnering relationships across Clinical R&D and J&J Benefit Risk Management (BRM) to identify, test, and adopt new processes, training, and systems to further advance or improve Clinical Research PV activities. Provide PV compliance guidance and support in the interpretation of regulatory requirements as they apply to Clinical R&D activities. Management oversight of the ESP (External Service Provider) Reporting process, including scheduling, tracking and management of ESP activities. Collaborate with GPS and clinical teams to manage and implement safety management plans with ESPs and provide PV reporting requirements. Ensures that ESP reporting to heath authorities are adequately documented into SCEPTRE and actions appropriately addressed. Liaison between Clinical R&D departments and BRM, ensuring that the processes established meet both the business needs and PV requirements and are implemented appropriately within the Clinical R&D organization. Participate and/or lead cross-functional, cross-pharma process improvement initiatives with BRM and business partner to ensure adequate exchange of adverse event data. Collaborate with BRM and Leiden PV to identify, develop, and implement new/improved processes, training, and systems to further advance PV operational activities. Provide PV compliance guidance and oversight in the development/revision of activities associated with PV regulatory reporting and clinical trial PV support. Ensures compliance with ICH, FDA, EU Directives and any other PV regulations. Participates in the management and coordination of the development of corrective action plans (CAPs) for any internal or external PV process audits/inspections, and ensure corrective activity is implemented and completed according to agreed time schedules. Collaborate with other R&D groups, as required. Performs and provides oversight to the performance of PV operational reviews of submission documents in preparation for submission to regulatory health authorities, and Clinical and Regulatory documents and data, as required. A minimum of a Bachelor's Degree in a clinical or scientific discipline is required, A Master's Degree or above is preferred. Must have a minimum of 6 or more years of previous Pharmaceutical industry experience. Of that, 5 or more years experience in PV safety compliance. Should have a working knowledge and show proficient application of the drug safety process, FDA regulations and guidance documents, EU Directives and ICH guidelines through assigned activities. In addition, he/she should have demonstrated leadership skills, a good understanding of clinical safety processes (clinical trials and spontaneous reports), effective communication and organizational skills, demonstrated problem-solving, decision making skills, and attention to detail and the ability to orchestrate multiple activities at once in order to accomplish a goal. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now