Pharmacovigilance Reporting Associate

Icon Plc

2+ years

Not Disclosed

China Shanghai Shi

10 Jan. 22, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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
Employer: ICON plc
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. Our mission is to shape the future of clinical development through innovation and excellence. We foster an inclusive work environment and welcome diverse talent to join our dynamic team.

Position Overview:

We are seeking a Pharmacovigilance Reporting Associate to join our team in Shanghai. This role involves preparing and reviewing safety reports related to clinical trials and post-marketing activities. The ideal candidate will ensure compliance with regulatory requirements while contributing to patient safety and regulatory adherence.

Key Responsibilities:

Safety Report Preparation:
- Prepare and review safety reports, including periodic safety updates and individual case safety reports (ICSRs), ensuring accuracy and regulatory compliance.
- Collect and analyze adverse event data from clinical trials and post-marketing sources to support the preparation of safety reports.
- Collaborate with cross-functional teams (clinical, regulatory, data management) to gather necessary information and resolve reporting issues.
Regulatory Compliance & Reporting:
- Ensure timely submission of safety reports to regulatory authorities and sponsors, adhering to deadlines and guidelines.
- Maintain up-to-date knowledge of regulatory requirements and best practices in pharmacovigilance reporting.

Required Qualifications & Skills:

Educational Requirements:
- Bachelor’s degree in life sciences, pharmacy, or a related field.
Experience & Expertise:
- Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
- Ability to prepare and review complex safety reports with excellent attention to detail and organizational skills.
Skills:
- Strong communication and collaboration skills, with experience working within multidisciplinary teams.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.

What ICON Offers:

Competitive Salary & Benefits:
- ICON offers a range of benefits focused on employee well-being and work-life balance, including:
  - Annual leave entitlements
  - Health insurance options for you and your family
  - Competitive retirement planning
  - Life assurance
  - Global Employee Assistance Programme (LifeWorks) providing 24/7 support
  - Flexible country-specific benefits (e.g., childcare vouchers, gym memberships, travel passes)
Career Development:
- ICON fosters a diverse culture and rewards high performance while nurturing talent.

Diversity & Inclusion:

At ICON, diversity, inclusion, and belonging are fundamental to our culture. We believe that our rich diversity drives innovation and helps us better serve our employees, patients, customers, and communities. ICON is committed to providing a workplace free from discrimination and harassment, ensuring all candidates are given equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Accommodation:

If you require any reasonable accommodation due to a medical condition or disability during the application process or to perform the essential functions of the role, please submit a request.

Application Instructions:

Interested candidates are encouraged to apply, even if not meeting all of the listed requirements. We welcome applicants for this role as well as other potential roles within ICON.

Current ICON employees: Please apply through the internal portal.

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