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Safety Associate Trainee

0-2 years
Not Disclosed
10 Oct. 10, 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 Description: Safety Data Processing Specialist

Overview: We are seeking a Safety Data Processing Specialist to review, assess, and process safety data across various service lines. This role involves managing information from multiple sources and distributing reports to both internal teams and external partners, ensuring compliance with applicable regulations, standard operating procedures (SOPs), and internal guidelines, all under the guidance of senior operations team members.

Essential Functions:

  • Prioritize and complete assigned training in a timely manner.
  • Process safety data in accordance with regulations, guidelines, SOPs, and project requirements.
  • Perform pharmacovigilance activities, including:
    • Collecting and tracking incoming Adverse Events (AEs) and endpoint information.
    • Determining the initial or updated status of incoming events.
    • Entering data into databases.
    • Coding AEs and products, writing narratives, and handling literature-related tasks.
  • Take on additional workflow responsibilities for assigned projects as directed by the operations team or manager.
  • Ensure productivity and quality standards are met.
  • Identify and report quality issues to a senior team member or mentor.
  • Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.
  • Maintain 100% compliance with all people practices and processes.
  • Perform other duties as assigned.

Qualifications:

  • High School Diploma or equivalent; Bachelor’s Degree in a scientific or healthcare discipline is preferred.
  • Good knowledge of medical terminology.
  • Strong verbal and written communication skills.
  • Ability to work collaboratively as a team player and contribute to team goals.
  • Proficient in Microsoft Office and web-based applications.
  • Self-motivated, flexible, and detail-oriented.
  • Ability to follow instructions and guidelines, utilize initiative, and work independently.
  • Strong time management skills with the ability to manage competing priorities and deadlines.
  • Willingness and aptitude to learn new skills across safety service lines.
  • Ensure the quality of deliverables aligns with agreed-upon terms.
  • Demonstrate IQVIA core values in daily tasks.
  • Role requires extensive use of a keyboard and telephone, necessitating accurate perception of speech.
  • Regular sitting for extended periods may be required, with occasional travel.
  • Flexibility to operate in shifts.

Join us in making a difference by ensuring the safety and well-being of individuals through meticulous data management and compliance.