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Description
Job Title:
Manager / Sr. Manager, Safety Information Management, GDS&RM
Job ID:
12322
Location:
Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary:
Regular
Category:
Drug Safety
Department:
Drug Safety - 4202
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
BS/MS in Computer Systems ore relevant work experience. 8+ years of Pharmaceutical Industry experience; minimum of 4 years experience working with or in a Drug Safety/Pharmacovigilance function. Must have in-depth knowledge of Drug Safety Systems, planning, implementation and configuration experience.
Current PMP (Project Management) certification is required.
Responsibilities will include but are not limited to the following:
Safety Information Management (SIM)
* Key point of contact with Celgene's Global IT department to ensure seamless collaboration and adherence to IT policies, processes and standards
* Create and update system-related or data entry policies, guidelines, and SOPS
* Support the management of the Safety Information Management budgets
* Provide support and partnership Business Intelligence staff
* Responsible as subject matter expert in support of pharmacovigilance and systems-related regulatory inspections and audits, including the management of corrective and preventive actions
Drug Safety Systems planning, implementation and change management
* Manage the execution of technical implementation of new or existing safety systems (including but not limited to ARISg, agXchnage,E2B)
* Oversee staff involved in application technical maintenance
* Analyze and revise existing system logic
* Collaborate with Global IT for application technical expertise
* Analyze and evaluate existing or proposed systems requirements in collaboration with business colleagues to determine system impact
* Oversee Business Intelligence activities and safety data query support
* Provide project management for technology implementations
* Manage/oversee system implementation activities from Requirements, gap analysis and design to training, workshops, prototyping, validation, implementation and ongoing support.
* Provide technical / process oriented guidance to Safety Information Management staff.
* Oversee application administration (including but not limited to ARISg, ARISj and agXchange)
* Manage the execution of system maintenance activities, including:
* Upgrades
* System administration
* Trouble-shoot, debug, implement corrective technical solutions
* Performs application business administration functions as required. Oversees changes to business area application access and approves usage of advanced functions.
* Oversee the use of programming and design techniques that ensure adherence to software development standards
* Process sophisticated ad hoc data outputs from safety systems
- program and execute scripts
- clean and verify data
* Manage data administration
- verify, clean-up, reconcile, and migrate
- perform MedDRA legacy conversion and upgrades
* Oversight of systems backup and recovery exercises for business continuity planning
User Support & Training
* Contribute to the development and planning of the international Drug Safety system support
* Manage all activities for consulting and user support maintaining a high-level of functional application support.
* Coordinate and support global and regional user group meetings
* Coordinate the tracking, analysis and trending of all systems issues
Project Budgets
* Manage project budgets including planning, payment monitoring
* Collaborates on the tracking of all project invoices related to asset purchases including all associated licensing and maintenance agreements associated with the capital projects).
Collaboration and Vendor Management:
* Liaises with GDS&RM Business Process Experts, Validation, Quality Assurance and Information Technology for change control
* Manage external vendor(s) providing project implementation support.
Technical Competencies/Knowledge:
* Expert knowledge of Oracle database, Oracle Developer, standard programming languages, web technology
* Expert knowledge of safety reporting applications, including but not limited to ARISg, ARGUS, ARISj, AgXchange, E2B and modules
* Knowledge of global regulatory requirements for worldwide pharmacovigilance
* Expert knowledge of Excel and Power Point
* Familiarity with reporting tools such as Business Objects and Universe Designer.
* Understanding of software development lifecycle development standards
* Expert knowledge of regulations around 21CFR part 11
* Application Configuration/build management, business process analysis, systems design, IQ, OQ, user acceptance testing & implementation experience in ARISg, ARISj, agXchange applications.
* Solid knowledge and practical experience with software engineering, designing and managing validated reliable high-transactions volume applications in Drug Safety.
* Experience in project management, portfolio management, and change management in a global environment
* Experience in planning and implementing application systems in a global environment
Skills/Knowledge Required:
* Excellent oral and written communication skills (fluency in written and spoken English)
* Strong presentation, facilitation, negotiation, collaboration and communication ability.
* Demonstrated knowledge of Drug Safety and pharmacovigilance processes as they relate systems
* Demonstrated project leadership, follow-up, critical, tactical and innovative thinking, problem solving and analytical skills
* Team player; open minded, creative thinker
* Ability to handle multiple projects simultaneously & critically assess pertinent information changes
* Ability to understand strategic objectives and create robust application solutions
* Capable of working effectively under pressure in a multi-cultural environment, at any level of the organization, with a variety of stakeholders
* Demonstrated effective project leadership skills
* Work with senior-level functional management to gather ideas and opportunities for new development areas
* Ability to maintain a good working relationship with the Global IT teams and internal business units.
* Contribute in maintaining an effective, open and supportive environment for the discussion of Global Drug Safety systems and application opportunities.
* Must be flexible and able to travel (approx 5% of time)
Celgene Leadership Competencies
* Promote Open Communication
* Create Global Mindset
* Demonstrate Adaptability
* Foster Risk Taking
* Foster Teamwork
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
33221193
Posted / Updated:
2/4/2012 3:51:21 AM
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