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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 April 17, 2025
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

Position: Pharmacovigilance Reporting Associate
Location: Shanghai, China
Job Code: JR126084
Company: ICON plc - Full Service & Corporate Support


About ICON:

ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON is committed to driving innovation and excellence in clinical development, fostering an inclusive work environment.


Key Responsibilities:

  • Safety Report Preparation: Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and regulatory compliance.

  • Data Collection & Analysis: Collect and analyze adverse event data from clinical trials and post-marketing activities.

  • Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements and industry standards in pharmacovigilance reporting.

  • Cross-functional Collaboration: Work closely with clinical, regulatory, and data management teams to resolve reporting issues.

  • Timely Submissions: Ensure safety reports are submitted on time to regulatory authorities and sponsors.


Qualifications:

  • 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.

    • Strong communication and collaboration skills.

    • Ability to manage multiple tasks in a fast-paced, regulated environment.


Benefits:

  • Competitive salary and comprehensive benefits.

  • Annual leave entitlements.

  • Health insurance options to suit your and your family’s needs.

  • Retirement planning offerings.

  • Global Employee Assistance Programme (LifeWorks) for 24-hour access to specialized professionals.

  • Life assurance and flexible, country-specific benefits such as childcare vouchers, bike schemes, gym memberships, and health assessments.


To Apply:
Visit the slug link to apply for the role:
pharmacovigilance-reporting-associate-shanghai-jr126084

Inclusion Statement:
ICON is dedicated to providing a workplace free of discrimination and harassment, ensuring equal opportunities for all applicants.