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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Dec. 20, 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 Opening: Pharmacovigilance Reporting Associate
Location: Shanghai, China
Company: ICON plc

About the Role:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Pharmacovigilance Reporting Associate to join our team in Shanghai. In this role, you will be responsible for ensuring the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. Your efforts will support patient safety and regulatory compliance by preparing safety reports in line with industry standards.

Key Responsibilities:

  • Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring compliance with regulatory standards.
  • Collect and analyze adverse event data from clinical trials and post-marketing sources to compile comprehensive safety reports.
  • Stay updated on regulatory requirements and best practices in pharmacovigilance reporting.
  • Work with cross-functional teams to gather necessary information and resolve reporting issues.
  • Ensure timely submission of safety reports to regulatory authorities and sponsors.

Your Profile:

  • Bachelor’s degree in life sciences, pharmacy, or a related field.
  • Experience in pharmacovigilance or drug safety, with a solid understanding of safety reporting and regulatory requirements.
  • Strong attention to detail, organizational skills, and the ability to handle complex reports.
  • Excellent communication and collaboration skills.
  • Ability to prioritize and manage tasks effectively in a fast-paced, regulated environment.

What ICON Offers:

  • Competitive salary and comprehensive benefits, including health insurance, retirement planning, and annual leave.
  • Employee assistance programs and flexible benefits.
  • A diverse, inclusive work culture that values high performance and nurtures talent.

At ICON, Diversity, Inclusion & Belonging are at the heart of our values. We are committed to providing an accessible and harassment-free workplace for all candidates.

How to Apply:
Visit our careers page to learn more and apply for the position. If you need accommodations due to a medical condition or disability, please inform us during the application process.