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5+ years
Not Disclosed
10 Sept. 11, 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

Work Schedule:
Other

Environmental Conditions:
Office-based

Job Description:

Position Overview:
At Thermo Fisher Scientific, we are committed to making a positive global impact by advancing science and improving health outcomes. As part of our mission to enable our customers to make the world healthier, cleaner, and safer, you will join a dynamic team and contribute to groundbreaking work. You will oversee a team of Safety Database Analysts and work directly with customers to ensure reliable, compliant, and efficient management of Safety Databases throughout all phases of their lifecycle.

Key Responsibilities:

  • Safety Database Management: Oversee the lifecycle management of Safety Databases, including migration processes.
  • System Validation: Apply your experience in Pharmacovigilance (PV) System Validation to ensure system reliability and compliance.
  • Reporting Tools: Utilize reporting tools effectively to deliver accurate and actionable data.
  • E2B Gateway: Set up and test E2B Gateway interfaces to ensure proper data transmission.
  • Audits and Inspections: Handle PV Technology audits and inspections, ensuring adherence to regulatory standards.
  • Team Leadership: Manage and mentor a team of PV Technology professionals, providing guidance and support.

Education and Experience:

  • Bachelor’s degree or equivalent in a relevant field with at least 5 years of experience in safety systems.
  • Equivalent combinations of education, training, and experience may also be considered.

Knowledge, Skills, and Abilities:

  • Influential Leadership: Strong ability to influence and lead cross-functional teams to meet objectives.
  • PV Systems Expertise: Broad understanding of PV systems, testing, and validation processes, with knowledge of global regulatory requirements.
  • Project Management: Proven track record of delivering PV Technology initiatives on time and within budget.
  • Technical Proficiency: Skilled in Microsoft Office and Safety Databases; familiarity with other PV software is a plus.
  • Critical Thinking: Excellent problem-solving, decision-making, and critical thinking skills.

About Us: At Thermo Fisher Scientific, our mission is to advance science and improve global health outcomes. As part of our team of over 100,000 colleagues, you will be valued for your diverse experiences, backgrounds, and perspectives. We are dedicated to integrity, intensity, innovation, and involvement. Join us in making a difference in the world.

Apply today: http://jobs.thermofisher.com

Thermo Fisher Scientific is an Equal Employment Opportunity/Affirmative Action Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.