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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Dec. 17, 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

About the Role:
ICON plc, a world-leading healthcare intelligence and clinical research organization, is seeking a Pharmacovigilance Reporting Associate to join our team. In this role, you will be responsible for the submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other applicable safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors. You will ensure timely compliance with company standards and regulatory requirements while maintaining strong relationships across functional units.

What You Will Be Doing:

  • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors within specified timelines.
  • Ensure the release of safety reporting intelligence for expedited and periodic reports to regulatory authorities, ethics committees, and investigators.
  • Maintain a strong understanding of ICON's safety reporting systems, processes, and Standard Operating Procedures (SOPs).
  • Perform oversight of assigned projects to ensure compliance with ICON, sponsor, and regulatory timeframes for safety information reporting.
  • Operate as a lead ensuring ownership and accountability of safety reporting activities for assigned projects.
  • Serve as support to the Safety Reporting Group management in activities including quality and compliance metric review, project resource tracking, client engagement, training oversight, and CAPA management.
  • Work with project team members, clients, investigators, and third-party vendors to maintain strong relationships and ensure smooth project execution.
  • Perform filing and quality control of documents submitted to the eTMF or other filing solutions, ensuring file readiness for audits or inspections.
  • Coach and mentor less experienced associates in safety reporting activities.
  • Participate in client and internal meetings and represent the Safety Reporting department for assigned projects.
  • Travel approximately 10% domestically and/or internationally as required.
  • Perform other duties as assigned by management.

What ICON Can Offer You:
At ICON, we recognize that our success depends on the quality of our people. We offer a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers a range of benefits, including:

  • Various annual leave entitlements
  • Health insurance options tailored to you and your family's needs
  • Competitive retirement planning options
  • Life assurance
  • Flexible, country-specific benefits such as childcare vouchers, gym memberships, and more

ICON’s Commitment to Diversity:
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our diverse workforce enables us to innovate and better serve our people, patients, customers, and communities. We are dedicated to creating an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.

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