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Pharmacovigilance Specialist

2+ years
Not Disclosed
10 Oct. 30, 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

Company: ICON plc

Location: Bulgaria

About ICON plc: ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.

Job Role:

As a Senior Pharmacovigilance Reporting Associate, you will be responsible for:

  • Submitting expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, regulatory authorities, ethics committees, investigators, and other stakeholders as agreed during study setup, ensuring compliance with specified timelines.
  • Maintaining a comprehensive understanding of ICON's safety reporting systems, processes, and standard operating procedures (SOPs).
  • Performing oversight of assigned projects to ensure timely reporting of safety information and release of global safety reporting intelligence.
  • Leading safety reporting activities and ensuring compliance with regulatory requirements and client obligations.
  • Supporting departmental activities, including quality and compliance metric review, finance tracking, and client engagement.
  • Collaborating with project team members, clients, investigators, and third-party vendors to maintain good relationships across functional units.
  • Maintaining project information in multiple databases and ensuring timely updates.
  • Preparing for audits and inspections and representing the department as designated.
  • Mentoring less experienced associates in safety reporting activities.

What ICON Can Offer You: ICON prioritizes the quality of our people, fostering a diverse culture that rewards high performance and nurtures talent. We offer a competitive salary and a range of additional benefits, including:

  • Various annual leave entitlements.
  • Health insurance tailored to your and your family's needs.
  • Competitive retirement planning options.
  • Access to a global Employee Assistance Programme, LifeWorks.
  • Life assurance and flexible country-specific optional benefits.

Diversity and Inclusion: At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are committed to providing an inclusive environment free of discrimination and harassment. All qualified applicants will receive equal consideration for employment.

Application Process: If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply. You may be exactly what we’re looking for at ICON.