Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Clinical Research, HealthcareIndustries

Position Overview

  • Location Type: Office
  • Job Type: Full time
  • Work Schedule: Standard (Mon-Fri)
  • Environmental Conditions: Office

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.

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

  • 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.

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

Skills

Oracle Argus
SQL
OBIEE
System configuration
Database management
Report development
Troubleshooting
SOP development
Vendor coordination

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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