Allergan Dir, Patient Safety Operations in Madison, New Jersey
Dir, Patient Safety Operations
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5162/other-jobs-matching/location-only
Apr 24, 2018Post 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 pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective 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 every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Director, Patient Safety Operations, Safety Systems, provides support and supervision for the development, upgrade, functionality, configuration, and business maintenance of key databases and systems utilized by Global Patient Safety & Epidemiology (GPSE). These systems include the Global Pharmacovigilance & Product Complaints (GPPC) database, (i.e., Argus Safety /Argus Affiliate, Business Objects), and other systems and tools that support Global Patient Safety & Epidemiology’s mission of monitoring and reporting patient and product safety, including E2B gateway, Literature Tracking tool, Safety Information and Reporting tool and signal detection.
Main Areas of Responsibilities
Manage Argus Safety, and related safety systems.
Provide expert support to system owners, and translate business user requirements into functional specifications. Interact with partners, service providers, third-party vendors, Research and Development Information Technology (RDIT), system owners within and outside GPSE and provide excellent customer support.
Liaise with the regional and local safety organization to provide business support for Argus Affiliate and Argus-J.
Serve as the business lead, leveraging strong project management skills, to drive continuous improvement projects, deliver business results and maintain compliance with regulatory requirements.
Plan and execute data migration strategies for product acquisitions and divestitures. Implement routine system and application upgrades including Medical Dictionary for Regulatory Activities (MedDRA) upgrades.
Serve as support for regulatory inspections and audits.
Provide oversight for a group of Safety professionals responsible for system configuration, report generation, system upgrades, system testing and other customer support activities as required.
Experience working with Contract Research Organizations (CROs), service providers, and several years of experience in vendor management
Defining and monitoring KPIs to achieve optimal performance
Understanding of contract review and/or negotiation
Involvement with US and global Pharmacovigilance regulations is desired
Knowledge of collection and reporting of Serious Adverse Events (SAEs) associated with investigational products (i.e. SAEs from Clinical Trials) as well as all AEs from post-marketing sources
Safety database experience required. Argus safety database experience desirable
Demonstrated knowledge and experience with a pharmacovigilance safety database (eg ARGUS/ARISg) including retrieval and navigation skills, and electronic exchange gateways (eg Axway). Argus-J experience is desirable
Experience with reporting tools (eg Business Objects (BO XI), Cognos)
Good understanding of Pharmacovigilance, including Good Vigilance Practices, Drug Safety processes, standards, conventions, and governance
Understanding of FDA and global Pharmacovigilance regulations
Cross product knowledge including familiarity with reference safety information (eg investigators’ brochures, package inserts, company core data sheets) and advanced regulatory reporting knowledge
Ability to manage a diverse staff, develop a cohesive team, and build positive morale
Selecting vendors; training service providers
1-3 years of clinical/research experience in the pharmaceutical/device industry
Ability to travel up to at least 20% of time, including international travel
- Relevant science degree (e.g. PharmD, PhD); Scientific knowledge and experience in the area of dermatology and/or medical aesthetics is preferred
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.