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Reference Number:
14684sc
Job Description:
Seeking an individual with in-depth Knowledge of Drug Safety Systems (Arisg, agXchange, E2B), planning, implementation, and configuration experience. This person shall be an integral part of the Safety Informatics team supporting Global Safety Systems.
Responsibilities will include but are not limited to the following:
Drug Safety Systems planning, implementation and change management
- Executing technical implementation of new or existing safety systems (Arisg, agXchnage,E2B)
- Oversee application technical maintenance
- Analyzing and revising existing system logic
- Collaboration with Global IT for application technical expertise
- Analyzing and evaluating existing or proposed systems requirements in collaboration with business colleagues to determine system impact
- Oversee 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 junior Safety Informatics staff.
- Provide application administration (ARISg, ARISj and agXchange)
- Manage the execution of system maintenance activities
- 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
Key Requirements/Knowledge:
- Expert knowledge of Oracle database, Oracle Developer, standard programming languages, web technology
- Expert knowledge of safety reporting applications: ARISg, 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
Skills/Knowledge Required:
Working experience & Education
- University degree in Computer Science or relevant work experience.
- 5 to 10 years of overall work experience
- 4 to 6 years in Information technology project management with concentration in Drug Safety/Pharmacovigilance systems.
- 5 to 7 years of Pharmaceutical Industry experience
Skills
- Excellent oral and written communication skills (fluency in written and spoken English)
- Strong presentation, facilitation, negotiation, collaboration and communication ability.
- 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
- Good people management skills for managing indirect staff as part of any given project team.
- 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
Knowledge
- 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
- Experience in managing and recruiting people
We do not sponsor
Experience Level:
Unspecified
Requirements:
ARISg, ARISj
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