Job Description

Employment Type: Full time Work Schedule: 11:00 AM to 7:00 PM local time

Position Overview

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!

This role serves as a subject matter expert for the day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database, Oracle Argus. The position ensures that performed tasks comply with SOPs, policies, industry standards, and applicable regulations. It involves providing technical solutions, supporting systems implementation and testing following change control procedures, and providing systems administration to support the requirements and initiatives of the PV Safety group.

Responsibilities

• Collaborates with PV business users to understand 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.
• Resolves and addresses end-user queries related to the Safety database.
• Supports routine dictionary upgrades.
• Liaises with the PV Safety database vendor for system upgrades, enhancements, issue resolutions, and ongoing 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 the 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 teams or clients 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, ensuring desired outcomes are achieved on time and in scope.
• Reviews and makes recommendations for process development and improvement.
• Manages assignments 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 providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Previous experience in case-processing.

Knowledge, Skills and Abilities:

• Experience in Argus J would be an advantage.
• System administration experience in Oracle Argus (including current knowledge of safety system configuration, database structure, mappings requirements, and transformation rules).
• Solid experience generating reports.
• SQL programming skills.
• Demonstrable record in safety data migrations.
• Knowledge of relational database structure and experience working with complex data systems.
• Good attention to detail.
• Problem-solving skills.
• Good written and verbal communication 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 communicate.

Location/Division Specific Information

• Location: Bulgaria, Serbia
• Division: Pharmacovigilance