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Senior Safety Specialist - Fso, Bulgaria

5+ years
Not Disclosed
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: Pharmacovigilance Specialist
Company: Thermo Fisher Scientific
Location: Office, Standard (Mon-Fri) Schedule

Job Description:
At Thermo Fisher Scientific, you will have the opportunity to make a positive impact on a global scale. Join our team in advancing science and research to deliver life-changing therapies. We aim to improve health outcomes across the world through innovative clinical trials and cutting-edge technologies. Your attention to detail and commitment to quality will help make the world healthier, cleaner, and safer.

Summary:
You will play a key role in the Pharmacovigilance (PV) department by performing day-to-day safety activities. This involves assessing, tracking, and evaluating safety data within a highly regulated environment and meeting strict timelines. Your role will include coordinating case reviews, regulatory reporting, and ensuring safety compliance across all related activities.

Key Responsibilities:

  • Manage day-to-day PV tasks, including data entry, case reviews, follow-ups, and safety reporting.
  • Participate in on-call duties for specific projects to ensure 24-hour case intake.
  • Stay updated with the latest PV regulations, practices, and safety guidelines.
  • Prepare and review safety reports for regulatory submissions.
  • Collaborate with internal teams, clients, and third-party vendors to ensure accurate and timely reporting.
  • Mentor junior team members and assist with project implementation.

Keys to Success:
Education and Experience:

  • Bachelor’s degree or equivalent in a relevant field.
  • Minimum of 2+ years of experience in PV or a related area.

Skills and Abilities:

  • Strong understanding of disease processes and pathophysiology.
  • Excellent communication and critical thinking skills.
  • Proficient in Microsoft Office and multiple database platforms.
  • Ability to manage multiple tasks, prioritize deadlines, and work independently.

Apply Today:
If you're driven by science and want to contribute to improving health outcomes, apply today and #StartYourStory with Thermo Fisher Scientific.

EEO/Affirmative Action Employer:
Thermo Fisher Scientific is committed to a diverse and inclusive workforce and does not discriminate based on any legally protected status.