Allergan Senior Director, Risk Management (Pharmacovigilance) in Irvine, California
Senior Director, Risk Management (Pharmacovigilance)
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/41/other-jobs-matching/location-only
Jun 03, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Oursuccess is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Join our bold team! Learn more at www.Allergan.com at http://www.allergan.com/ .
The Director, Global Risk Management is responsible for the strategic leadership and operational management of Allergan’s risk management programs, including Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). This includes working collaboratively with cross functional teams to provide strategic risk management guidance and ensure consistency in the development, implementation, monitoring, and measurement of effectiveness of RMPs and REMS across the Allergan portfolio. Additionally, the Director/Senior Director, Global Risk Management is responsible for communication and training related to risk management activities, as well as performance management.
Main Areas of Responsibilities
Develop a culture of innovation and best practices for risk management, benefit/risk assessment, and safety/risk communications
Provide strategic guidance and leverage best practices to ensure development and implementation of robust and effective global risk management strategies
Work collaboratively across organizational and geographical boundaries to ensure standard and consistent approach to align global risk management strategies
Serve as risk management point of contact during internal audits and/or external inspections with health authorities
Establish processes, systems, and tools to support a proactive approach to risk management throughout the Allergan organization
Serve as key interface between the Global Risk Management team and other functions related to risk management forecasting, planning, and budgeting
Oversee development and execution of risk minimization strategies
Identify and engage with external consultants and vendors, as needed to meet risk management business objectives
Communication and Training
Develop, deliver, and maintain a risk management training program for Global Risk Management colleagues, other GPS&E colleagues, as well as colleagues outside of safety involved in risk management activities
Evaluate emerging regulations and industry trends in global risk management requirements and determine impact to Allergan processes and systems
Actively participate in meetings, attend conferences, and network with subject matter experts on risk management topics
Share knowledge and expertise of risk management concepts, principles, and tools with internal and external colleagues
- Director: MD/PharmD/PhD with 10 years pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, Clinical Development, or Medical Affairs and 5 years of direct experience in global risk management
Established expertise and knowledge of Risk Management concepts, principles, tools, and processes. Quality improvement and/or Six Sigma training, preferred
Demonstrated knowledge and advanced understanding of global Pharmacovigilance and Risk Management legislation and regulatory requirements
Experience with internal audits and PV inspections conducted by global health authorities such as FDA, MHRA, etc.