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Pharmacovigilance Reporting Associate

2+ years
Not Disclosed
10 Dec. 4, 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

Pharmacovigilance Reporting Associate

Location: Shanghai, China
Company: ICON plc

About ICON
ICON plc is a global leader in healthcare intelligence and clinical research, committed to driving innovation and excellence in clinical development. We foster an inclusive culture, encouraging collaboration and diversity to shape the future of healthcare.

We are currently seeking a Pharmacovigilance (PV) Reporting Associate to join our team in Shanghai, China. This role offers the opportunity to play a critical part in ensuring patient safety and regulatory compliance through the preparation of accurate and timely safety reports.


Key Responsibilities

  • Safety Reporting: Prepare and review safety reports, including Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs), ensuring compliance with regulatory standards.

  • Data Analysis: Collect and analyze adverse event data from clinical trials and post-marketing sources to create comprehensive safety summaries.

  • Regulatory Compliance: Stay updated on regulatory requirements and industry best practices for pharmacovigilance reporting.

  • Collaboration: Work closely with cross-functional teams, such as clinical, regulatory, and data management, to gather information and resolve reporting issues.

  • Timely Submissions: Ensure safety reports are submitted to regulatory authorities and sponsors within established deadlines.


Your Profile

Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.

  • Experience in pharmacovigilance or drug safety, with a strong understanding of reporting processes and regulatory frameworks.

Skills

  • Excellent attention to detail and organizational skills for preparing and reviewing complex safety reports.

  • Strong communication and teamwork abilities to effectively collaborate with multidisciplinary teams.

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


What ICON Offers

At ICON, we value our people and reward high performance while nurturing talent.

Benefits

  • Annual leave: Competitive entitlements tailored to country-specific standards.

  • Health coverage: Comprehensive options for you and your family.

  • Retirement planning: Competitive offerings to ensure long-term financial security.

  • Employee Assistance Programme (EAP): Access to a global network of professionals for personal and family well-being support.

  • Life assurance and flexible benefits, such as childcare vouchers, gym memberships, travel subsidies, and more.

Our Culture

  • Diversity & Inclusion: ICON is committed to fostering a diverse, inclusive workplace that drives innovation.

  • Accessibility: Reasonable accommodations are provided for candidates and employees with disabilities to ensure a supportive work environment.


Apply Today

If you are passionate about pharmacovigilance and want to make a meaningful impact, we encourage you to apply—even if you feel you may not meet all requirements. You might be the perfect fit for this role or another opportunity at ICON.

Current ICON employees: Apply here.
Explore your future at ICON and join us in shaping the future of clinical development.