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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Dec. 19, 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

About ICON:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us as we shape the future of clinical development.

Role Overview:
As a Pharmacovigilance Reporting Associate at ICON, 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, support patient safety, and contribute to the effective management of safety data.

Key Responsibilities:

  • Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
  • Collect and analyze adverse event data from clinical trials and post-marketing sources.
  • Stay up-to-date with regulatory requirements and industry best practices in pharmacovigilance reporting.
  • Collaborate with cross-functional teams, including clinical, regulatory, and data management, to resolve reporting issues and gather necessary information.
  • Ensure timely submission of safety reports to regulatory authorities and sponsors according to deadlines and guidelines.

Profile Requirements:

  • 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.
  • Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports.
  • Strong communication and collaboration skills, with the ability to work effectively within multidisciplinary teams.
  • Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.

What ICON Can Offer You:
ICON values the quality of its people. In addition to a competitive salary, we offer a wide range of benefits designed to support your well-being and work-life balance, including:

  • Various annual leave entitlements
  • Comprehensive health insurance options for you and your family
  • Competitive retirement planning offerings
  • Access to the Global Employee Assistance Programme, LifeWorks
  • Life assurance
  • Country-specific optional benefits, including childcare vouchers, bike purchase schemes, gym memberships, and more.

For more details on the benefits we offer, visit our careers site.

Diversity & Inclusion:
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We embrace diversity and are committed to providing an inclusive and accessible environment for all candidates. ICON ensures equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you require reasonable accommodation due to a medical condition or disability, please let us know.

Interested but unsure if you meet all the requirements?
We encourage you to apply – there's a strong chance you have the skills and experience we're looking for.

Are you a current ICON Employee? Click here to apply.