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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 Title: 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 the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements while contributing to the effective management of safety data to support patient safety and regulatory compliance.

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 prepare comprehensive safety reports.
  • Maintain up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
  • Collaborate with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve reporting issues.
  • Ensure the timely submission of safety reports to regulatory authorities and sponsors, adhering to deadlines and guidelines.

Your Profile:

  • Bachelor's degree in life sciences, pharmacy, or a related field.
  • Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
  • Strong attention to detail, organizational skills, and the ability to prepare and review complex safety reports accurately.
  • Excellent communication and collaboration skills, with experience working within multidisciplinary teams.
  • Ability to manage multiple tasks and prioritize 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.
  • An inclusive, diverse work culture that fosters high performance and nurtures talent.

At ICON, Diversity, Inclusion & Belonging are integral to our culture and values. We are committed to providing an accessible, harassment-free workplace for all candidates and promoting equality in hiring practices.

How to Apply:
If you're interested in this role, even if you don’t meet all of the requirements, we encourage you to apply! You could be the perfect fit for this role or other opportunities at ICON.

For more details or to apply, visit our careers site.