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Pharmacovigilance Reporting Associate

2+ years
Not Disclosed
10 Dec. 14, 2024
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

Here’s a refined version of the Pharmacovigilance Reporting Associate role at ICON plc:


Position: Pharmacovigilance Reporting Associate

Location: Shanghai, China
Company: ICON plc
Division: Healthcare Intelligence & Clinical Research


About ICON plc

ICON plc is a leading global healthcare intelligence and clinical research organization. We are dedicated to fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.


About the Role

As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for preparing and reviewing safety reports related to clinical trials and post-marketing activities. This role ensures compliance with regulatory requirements and plays a critical part in managing safety data to support patient safety and regulatory compliance.


Key Responsibilities

  • Safety Reports Preparation & Review: Prepare and review safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), ensuring compliance with regulatory standards.
  • Adverse Event Data Analysis: Collect and analyze adverse event data from clinical trials and post-marketing sources to support comprehensive safety reporting.
  • Regulatory Knowledge: Stay up-to-date with regulatory requirements and industry best practices related to pharmacovigilance reporting.
  • Cross-Functional Collaboration: Work with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
  • Timely Submissions: Ensure the timely submission of safety reports to regulatory authorities and sponsors, adhering to deadlines and guidelines.

Your Profile

  • Education: Bachelor's degree in life sciences, pharmacy, or a related field.
  • Experience: Experience in pharmacovigilance or drug safety with a strong understanding of safety reporting processes and regulatory requirements.
  • Skills:
    • Excellent attention to detail and organizational skills for accurate report preparation.
    • Strong communication and collaboration skills, with experience working within multidisciplinary teams.
    • Ability to manage multiple tasks effectively in a fast-paced, regulated environment.

What ICON Offers You

At ICON, we value the quality of our people, and we prioritize fostering a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits tailored to support your well-being and work-life balance, such as:

  • Various annual leave entitlements
  • Health insurance offerings for you and your family
  • Retirement planning to maximize savings
  • Global Employee Assistance Program (LifeWorks) with 24/7 access to over 80,000 specialized professionals
  • Life assurance and additional country-specific benefits like childcare vouchers and subsidized travel passes

Diversity, Inclusion & Belonging

ICON is committed to diversity and inclusion, creating an accessible environment for all candidates. We are dedicated to providing a workplace free of discrimination and harassment, ensuring equal consideration for employment.


Interested?

Even if you don’t meet all the qualifications, we encourage you to apply—there’s a chance you’re the perfect fit for this role or other opportunities at ICON.

For more information on benefits, click here.


This version provides a clear, concise summary of the job while focusing on the key responsibilities and benefits. Let me know if you’d like further adjustments!