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10 Dec. 11, 2024
Job Description
Job Type: Full Time Remote 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: Safety Database Manager
Location: Not Specified
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Job Description:

At Thermo Fisher Scientific, we are dedicated to making a positive global impact through meaningful work. Join us in bringing our mission to life by enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the necessary resources to achieve career goals while advancing science and delivering life-changing therapies. With clinical trials conducted in over 100 countries and continuous development of novel frameworks for clinical research, we span across laboratory, digital, and decentralized clinical trial services. Your focus on quality and accuracy will improve health outcomes that communities depend on, now and in the future.

Discover Impactful Work:

As a Safety Database Manager, you will lead a team of Safety Database Analysts and work closely with customers to ensure the delivery of reliable, compliant, and efficient safety database solutions throughout their lifecycle.

A Day in the Life:

  • Oversee the lifecycle management of LSMV (Life Safety Management Validation), including safety database migration.
  • Manage and ensure compliance with previous experience in Pharmacovigilance (PV) system validation.
  • Work with reporting tools and provide E2B Gateway set-up and testing.
  • Participate in PV tech audits and inspections.
  • Lead and manage a team of PV tech professionals to deliver on project goals.

Education:

  • Bachelor’s degree or equivalent in a relevant field.
  • Minimum of 5+ years of safety systems experience.
  • In some cases, a combination of education, training, and/or directly related experience may be considered as an equivalent to the required qualification.

Knowledge, Skills & Abilities:

  • Strong influential skills, capable of leading cross-functional teams to meet objectives.
  • Broad understanding of PV systems, testing, validation processes, and global regulatory requirements.
  • Strong proficiency in delivering PV technology initiatives on time and within budget.
  • Knowledge of Safety Databases and PV software is desirable.
  • Proficient in Microsoft Office products and safety databases.
  • Excellent critical thinking, problem-solving, and decision-making skills.

Why Join Us?

Thermo Fisher Scientific is committed to fostering a diverse and inclusive work environment where your experiences, backgrounds, and perspectives are valued. Together, we accelerate research, drive technological innovation, and support patients in need.