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Senior Drug Safety Physician

2+ years
Not Disclosed
10 Sept. 26, 2024
Job Description
Job Type: 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 Opportunity: Senior Drug Safety Physician

As a Senior Drug Safety Physician, you will be responsible for performing medical and safety monitoring activities for assigned projects. You will contribute to the medical review, analysis, and guidance of all required safety reports and act as a Subject Matter Expert (SME) in various capacities, including presales activities and audits/inspections.

Key Responsibilities:

  • Maintain a thorough understanding of the adverse event and safety profiles of assigned products, including labeling documents, data handling conventions, and client guidelines, as well as global drug safety regulations.
  • Stay informed about global regulatory requirements and reporting obligations, organizing your workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
  • Communicate and discuss review process issues with your Line Manager, Project Leader, or designated personnel.
  • Interact with internal and external stakeholders to resolve issues effectively.
  • Attend and/or present at client and cross-functional meetings alongside other stakeholders, serving as an SME.
  • Assist the Project Lead or Functional Lead during audits and inspections.
  • Provide input for process improvements and work closely with the Project Lead or Functional Lead to ensure that all Key Performance Indicators (KPIs) are met.
  • Act as the pharmacovigilance representative and safety scientist for assigned projects.
  • Participate in and support bid defense meetings.
  • Mentor junior Drug Safety Physicians as needed.

If you’re ready to leverage your expertise and make a meaningful impact in drug safety, we’d love to hear from you!