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Pharmacovigilance Reporting Specialist

2+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Remote 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

Job Opportunity: Pharmacovigilance Reporting Specialist

Company: ICON plc
Location: Sofia, Bulgaria
Job Type: [Insert Job Type]

Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development, advancing research from molecule to medicine.

Job Summary

We are seeking a Pharmacovigilance Reporting Specialist to join our team. This role involves the submission of safety reports, maintaining compliance with regulatory standards, and ensuring the integrity of safety reporting processes.

Key Responsibilities

  • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, and safety information to clients, regulatory authorities, and other stakeholders within specified timelines.
  • Release safety reporting intelligence for expedited and periodic reports to regulatory authorities and ethics committees.
  • Provide expertise in safety reporting processes, maintaining a comprehensive understanding of ICON's systems and procedures.
  • Oversee assigned projects to ensure compliance with ICON, Sponsor, and regulatory timeframes for safety information reporting.
  • Collaborate with project team members, clients, investigators, and third-party vendors to build strong working relationships.
  • Maintain project information in multiple databases, ensuring timely updates.
  • Assist in the development of departmental Standard Operating Procedures (SOPs) and work procedures.
  • Perform quality control and filing of documents to ensure audit readiness.

Requirements

  • Bachelor's degree in life sciences.
  • 4 to 6 years of experience in pharmacovigilance.
  • Fluency in English.

Benefits of Working at ICON

At ICON, we invest in our employees through a continuous learning culture. Our comprehensive benefits package includes:

  • Competitive salary and variable pay.
  • Various annual leave entitlements.
  • Health insurance options tailored for you and your family.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Programme for family well-being.
  • Flexible benefits, including childcare vouchers and discounted gym memberships.

Commitment to Diversity

ICON is an equal opportunity employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require accommodations during the application process due to a medical condition or disability, please let us know.