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Senior Programmer Analyst

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance (PV) Safety Database Specialist
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 advancing science through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries, your dedication to quality and accuracy will enhance health outcomes that communities rely on now and in the future.

Purpose:
As a subject matter expert in day-to-day application configuration and maintenance of the Pharmacovigilance (PV) Safety database (Oracle Argus), you will ensure compliance with SOPs, industry standards, and applicable regulations. You will provide technical solutions, support systems implementation and testing, and manage systems administration to support the needs of the PV Safety group.

Responsibilities include but are not limited to:

  • Collaborate with PV business users to understand requirements and recommend effective solutions.
  • Create custom and ad-hoc reports from the PV Safety database using built-in tools, OBIEE, or SQL.
  • Develop and validate aggregate safety reports.
  • Troubleshoot and address end-user queries related to the Safety database.
  • Support routine dictionary upgrades.
  • Liaise with the PV Safety database vendor for system upgrades, enhancements, issue resolutions, and ongoing projects.
  • Assist in the development of SOPs for the PV Safety database.
  • Support internal and external audits of the PV Safety database.
  • Manage changes to the PV Safety database under PPD change control policies, including configuration changes and system upgrades.
  • Create new tenants within the PV Safety database and develop distribution rule configurations.
  • Lead data migration and validation projects, ensuring high-quality deliverables.
  • Interact with project teams or clients to gather feedback on deliverables.
  • Provide programming support for safety data review, ad-hoc reports, and other activities.
  • Lead project initiatives to ensure desired outcomes are achieved on time and within scope.
  • Review and recommend process improvements.
  • Manage assignments to meet timelines and deliver high-quality work.
  • Estimate 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 providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills, and Abilities:

  • System administration experience in Oracle Argus, with current knowledge of safety system configuration and database structure.
  • Strong experience in generating reports and SQL programming skills.
  • Demonstrated record in safety data migrations.
  • Knowledge of relational database structures and experience with complex data systems.
  • Proficient in one or more programming languages.
  • Strong attention to detail and problem-solving skills.
  • Good written and verbal communication skills.
  • Ability to organize and manage multiple assignments with challenging timelines.
  • Ability to adapt to changing priorities.
  • Demonstrated leadership, initiative, and motivation.
  • Ability to mentor and direct the work of junior staff.
  • Effective communication skills 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. Join us and see how our colleagues explain the reasons to work with us. As one team of over 100,000 colleagues, we share common values—Integrity, Intensity, Innovation, and Involvement—working together to accelerate research and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Apply today! Thermo Fisher Careers