Allergan Manager Risk Management (Pharmacovigilance) in Irvine, California
Manager Risk Management (Pharmacovigilance)
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/42/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 Manager, Global Risk Management is responsible for the planning, project management, implementation, monitoring, and evaluation of effectiveness of additional risk minimization activities in risk management programs, as well as monitoring of additional pharmacovigilance activities including Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). This may include facilitating meetings, providing risk management knowledge and expertise to cross functional teams, managing vendors, communicating with internal and external colleagues, developing/delivering training programs, monitoring implementation, providing status reports, and ensuring post-marketing risk management commitments are met.
Main Areas of Responsibilities
Participate to the development and execution of risk minimization strategies
Ensure the implementation of risk minimization activities globally according to risk management documents, including RMPs and REMS
Provide risk management expertise (e.g., regulations, processes, principles, methods, tools, best practices) to cross-functional teams
Measure compliance with risk management post-marketing commitments and provide status reports
Support inspections and audits specific to RMPs and REMS
Manage risk management projects, including project planning, budgets, vendors, communication, etc.
Liaise with vendors to execute on Risk Minimization activities
Monitor/track implementation of additional PV (e.g., PASS, PAES) and/or additional risk minimization activities using designated tracking tools
Schedule and facilitate cross-functional risk management team meetings; take minutes; follow up on action items
Act as company representative on shared risk management programs
Communication and Training
Facilitate communication within cross-functional risk management teams, including safety, regulatory, clinical, medical affairs, marketing, etc.
Prepare and deliver training programs on implementation of risk management activities
Liaise with Local Safety Officers to implement risk minimization activities, as needed
Escalate risk minimization issues to Risk Management Core Teams, Global Pharmacovigilance & Risk Management, Safety Leadership Team, and/or Global Safety Board, as needed
•Demonstrated knowledge of ICH, FDA, EMA, and other regulations and requirements related to risk management
•Solid planning, organizational, problem solving, and time management skills
•Self-motivated, independent, and able to handle multiple complex and competing priorities simultaneously
•Excellent verbal and written communication skills; able to relate to colleagues both inside and outside of the organization at various levels
•Proven ability to establish sound working relationships with colleagues cross culturally and cross functionally, provide appropriate feedback to colleagues and management, and influence where direct reporting relationships do not exist
•Proven experience in group facilitation - ability to drive teams to make decisions & achieve deliverables within agreed parameters & timelines
•Technical expertise with analytical tools and resources (e.g. MS Word, PowerPoint, Excel).
•Project management professional (PMP) certification and Quality Improvement and/or Six Sigma training, would be an asset
Manager: B.S/M.S in health science required, significant advanced training PharmD, PhD, or equivalents preferred with 3 years pharmaceutical industry experience in one of the following areas: Pharmacovigilance, Risk Management, Epidemiology, Regulatory, Clinical or Medical and 1-2 years of direct experience in REMS/RMP program management preferred