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Patient Safety Associate

1+ years
Not Disclosed
10 March 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Patient Safety Associate

Employment Type: Full-Time

Location: Remote

Job Description:

The Patient Safety Associate will be responsible for assisting in the day-to-day execution of pharmacovigilance and safety-related projects. This includes processing safety information, ensuring compliance with regulatory requirements, and supporting patient safety monitoring programs. The role involves working with devices, prescription drugs, OTC products, and consumer goods, while adhering to Good Pharmacovigilance Practices (GPV) and client protocols.

Key Responsibilities:

  • Act as part of the Patient Safety & Risk Management (PS & RM) Team to meet project outcomes and deliverables.
  • Ensure that all adverse events (AEs) and product complaints are reported and followed up according to client procedures.
  • Evaluate and process adverse event reports from various channels, assessing seriousness based on regulatory criteria.
  • Maintain the integrity of safety data in GxP databases and associated documentation.
  • Generate project reports and track KPIs to meet client and regulatory requirements.
  • Participate in internal and external audits to ensure compliance.
  • Provide after-hours safety-related telephone services as required.
  • Act as a subject matter expert and mentor for other team members.
  • Assist the Pharmacovigilance Manager as needed.
  • Contribute proactively to improving business processes.

Required Qualifications & Experience:

  • Education: Health Science degree or equivalent.
  • Experience: Minimum 12 months in a drug safety or equivalent role within a regulated industry (pharmaceutical or medical devices).
  • Regulatory Knowledge:
    • Good understanding of adverse event management and reporting requirements in Australia and New Zealand.
    • Familiarity with EU and APAC pharmacovigilance regulations.
  • Technical Skills:
    • Experience with safety databases and document management systems.
    • High attention to detail and strong computer literacy.
  • Soft Skills:
    • Strong communication, organizational, and problem-solving abilities.
    • Experience in SOP writing and process documentation.

Application Process:

Interested candidates can apply through the company's official portal.