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Programing Analyst Who Specialized In Computer System Validations, Pharmacovigilance

1+ years
Not Disclosed
10 Dec. 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

Job Title: Validation Specialist, Pharmacovigilance
Location: Bulgaria, Serbia
Work Schedule: Other
Environmental Conditions:

  • Office-based

Job Description:

At Thermo Fisher Scientific, we are driven by our mission to make the world healthier, cleaner, and safer. Join our global team and contribute to developing solutions that address some of the world’s toughest challenges, such as protecting the environment, ensuring food safety, and advancing cancer research. We provide our teams with the resources they need to achieve their career goals while supporting groundbreaking scientific innovations.

Location/Division Specific Information:

  • Location: Bulgaria, Serbia
  • Division: Pharmacovigilance

Responsibilities:

  • Assess and define assigned validation projects.
  • Write, review, and implement validation protocols for standard and customized systems.
  • Validate Pharmacovigilance (PV) Systems.
  • Raise discrepancies and close out test documentation.
  • Liaise with internal teams and vendors to address OQ failures, prepare summaries of observations, and present evidence during team meetings.
  • Conduct deviation investigations (OQ/PQ), including validation failures, complaints, and investigations. Identify and implement corrective actions.
  • Resolve technical issues in collaboration with IT and QA departments.
  • Communicate effectively with both internal and external clients.

Education:

  • Bachelor's degree (or equivalent combination of education, training, and relevant work experience).

Experience:

  • Minimum of 2 years experience in Patient Safety Computer Systems implementation, preferably in the biotech or pharmaceutical sector.
  • Experience with Argus, Gateways, and other PV systems AI platforms.
  • Self-motivated with strong time-management skills.

Knowledge, Skills & Abilities:

  • Solid understanding of regulatory standards and SOPs.
  • Experience in Computer Systems Validation, including execution of OQ and PQ.
  • Attention to detail with the ability to identify and remediate issues during testing.
  • Highly effective verbal and written communication skills, including technical authorship.
  • Proficiency in Microsoft Office (Word, Excel).

Why Join Us?

Thermo Fisher Scientific is an equal opportunity employer, fostering an inclusive and diverse work environment where your experiences, backgrounds, and perspectives are valued. Join us and help accelerate scientific research, solve complex challenges, and improve patient outcomes.