Pharmacovigilance Reporting Associate

2+ years

Not Disclosed

Shanghai Shi

10 Feb. 11, 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

Pharmacovigilance Reporting Associate – Shanghai, China

Company: ICON Plc
Location: Shanghai, China
Salary: Competitive
Start Date: January 18, 2025
Closing Date: February 17, 2025

About ICON Plc

ICON Plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing drug development and patient safety. We foster an inclusive and innovative work environment where talent thrives, and we invite you to be part of our mission to revolutionize clinical research.

Role Overview

As a Pharmacovigilance Reporting Associate, you will play a critical role in ensuring the accuracy and compliance of safety reports related to clinical trials and post-marketing activities. You will collaborate with cross-functional teams to manage safety data, contribute to regulatory compliance, and uphold the highest standards of patient safety.

Key Responsibilities:

Prepare and review safety reports, including Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs), ensuring accuracy and regulatory compliance.
Collect, analyze, and interpret adverse event data from clinical trials and post-marketing sources.
Stay up to date with pharmacovigilance regulations and industry best practices to maintain compliance.
Work closely with clinical, regulatory, and data management teams to gather information and resolve reporting issues.
Ensure timely submission of safety reports to regulatory authorities and sponsors.

Qualifications & Skills:

Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
Experience in pharmacovigilance, drug safety, or regulatory reporting.
Strong attention to detail with the ability to analyze and compile complex safety data.
Excellent organizational and communication skills, with experience collaborating in cross-functional teams.
Ability to manage multiple priorities in a fast-paced regulatory environment.

What ICON Offers:

ICON Plc values its employees and provides a competitive compensation package along with a wide range of benefits:

Flexible annual leave and well-being programs.
Comprehensive health insurance options for employees and their families.
Retirement planning benefits to support long-term financial security.
Global Employee Assistance Program (EAP) for personal and professional support.
Optional country-specific benefits, including gym memberships, childcare vouchers, and travel subsidies.

At ICON, diversity and inclusion are integral to our culture. We are committed to creating an accessible workplace free from discrimination and encourage candidates of all backgrounds to apply.

Interested in this opportunity? Apply today and be part of a team shaping the future of clinical development!

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Pharmacovigilance Reporting Associate

Job Description

Pharmacovigilance Reporting Associate – Shanghai, China

About ICON Plc

Role Overview

Key Responsibilities:

Qualifications & Skills:

What ICON Offers:

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