Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!
Location/Division Specific Information
Bulgaria, Serbia, Pharmacovigilance
Working hours: from 10am to 6pm local time
Purpose:
Subject matter expert of day-to-day aggregate reports and activities in PV Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations.
Responsibilities include but are not limited to:
- Creating, running, generating aggregate reports - DSUR, PADER, PBRER.
- 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.
- Leads data migration and validation projects
- Interacts with project team or client and seeks feedback on deliverables.
- 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.
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:
- Experience in Oracle Argus
- Strong experience generating reports
- SQL programming skills would be an advantage
- Demonstrable record in safety data migrations would be an advantage
- Experience working with complex data systems
- 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
- 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.
