Work Schedule
Other
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Purpose:
Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group.
Responsibilities include but are not limited to:
- Collaborates with PV business users to understand the requirements and recommend solutions.
- Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL.
- Develops and validates aggregate safety reports.
- Troubleshoots and addresses end user queries related to the Safety database.
- Supports routine dictionary upgrades.
- Liaises with PV Safety database vendor for system upgrades and enhancements, issue resolutions and on-going projects.
- Assists in the development of SOPs for the PV Safety database.
- Assists with internal and external audits of the PV Safety database.
- Manages changes to the PV Safety database under PPD change control policy, including configuration changes and system upgrades.
- Creates new tenants within the PV Safety database.
- Develops distribution rule configurations within the PV Safety database.
- Leads data migration and validation projects including creation of Data Migration Plans, Design Specifications and Summary Reports to ensure data migration activities meet requirements, are complete and accurate and delivered to a high-quality.
- Interacts with project team or client and seeks feedback on deliverables.
- Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities.
- Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope.
- Reviews and makes recommendations for process development and improvement.
- Manages assignment to meet timelines and deliver high quality work.
- Estimates effort to assist in bidding activities or cost construction.
Qualifications:
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Knowledge, Skills and Abilities:
- System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules
- Strong experience generating reports
- Strong SQL programming skills
- Demonstrable record in safety data migrations
- Knowledge of relational data base structure and experience working with complex data systems
- Proficient of one or more programming languages
- Strong attention to detail
- Problem solving skills
- Good written and verbal communications skills
- Ability to independently and effectively organize and manage multiple assignments with challenging timelines
- Ability to adapt and adjust to changing priorities
- Demonstrated leadership, initiative and motivation
- Ability to mentor and direct the work of junior staff
- Ability to communicates effectively within a multi-disciplinary team
- Ability to complete assigned tasks on time and within budget
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.