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Safety Specialist II

Posted 2024-11-14

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💎 Seniority level: Middle, 3-5 years

📍 Location: United States

💸 Salary: 72500 - 108700 USD per year

🔍 Industry: Clinical research services, precision medicine

🏢 Company: Precision for Medicine

⏳ Experience: 3-5 years

🪄 Skills: LeadershipProject ManagementCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringAttention to detailOrganizational skillsTime ManagementWritten communication

Requirements:
  • 4-year college degree or equivalent experience ideally in Pharmacy, Nursing, or scientific discipline.
  • 3-5 years of clinical trial and pharmacovigilance experience.
  • Working knowledge of GCP/ICH guidelines and the clinical development process.
  • Health care professional qualifications (i.e., RN, BSN, MD, PharmD).
  • Hands-on experience with global safety databases and SAE case processing.
  • Proficient in MedDRA and WHO Drug coding.
Responsibilities:
  • Intake and triage of serious adverse event (SAE) reports.
  • Provide guidance and safety expertise on pharmacovigilance practices.
  • Interface with sponsors and vendors regarding drug safety.
  • Participate in the setup of a safety database.
  • Perform medical coding and composition of individual case safety reports (ICSRs).
  • Review and draft safety reporting plans and training materials.
  • Mentor or train new pharmacovigilance staff.
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🔥 Safety Specialist II
Posted 2024-11-13

📍 United States

🧭 Regular Full-Time

💸 72500 - 108700 USD per year

🔍 Clinical Research and Development

🏢 Company: Precision Medicine Group👥 1001-5000💰 $35.2m on 2021-03-25PharmaceuticalBiotechnologyMedicalPrecision MedicineHealth Care

  • 4-year college degree in Pharmacy, Nursing, or a scientific or healthcare discipline.
  • 3-5 years of clinical trial, pharmacovigilance, or drug safety experience.
  • Advanced knowledge of the organization and structure of clinical studies.
  • Good understanding of technical and content knowledge.
  • Solid knowledge of FDA safety regulations, EMA, and other global safety regulations.
  • Experience with global safety databases and SAE case processing.

  • Intake, triage, processing, evaluation, and reporting of incoming Serious Adverse Event (SAE) reports.
  • Serve as primary safety specialist on complex studies.
  • Provide guidance on Pharmacovigilance best practices.
  • Interface with sponsors and vendors for drug safety processes.
  • Participate in the set-up of safety databases.
  • Perform data entry, medical coding, and narrative writing for individual case safety reports.
  • Prepare and review project-specific safety reporting plans and training materials.
  • Mentor or train new staff and support department development initiatives.

LeadershipProject ManagementProject CoordinationJiraCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringAttention to detailOrganizational skillsTime ManagementWritten communicationMultitasking

Posted 2024-11-13
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