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Pharmacovigilance Reporting Specialist

4-6 years
Not Disclosed
10 Sept. 27, 2024
Job Description
Job Type: 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

Pharmacovigilance Reporting Specialist - Sofia, Bulgaria

About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical research from molecule to medicine. We provide outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations, always placing patients at the center of our work. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.

At ICON, our people are our greatest asset. They are at the core of our culture and the driving force behind our success. We seek individuals who are passionate about their work and committed to achieving excellence.

Key Responsibilities

  • Safety Reporting: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors as per project timelines.
  • Safety Reporting Intelligence: Release safety reporting intelligence for expedited and periodic reports and line listings, adhering to company procedures and timelines.
  • Expertise in Safety Reporting: Provide in-depth expertise in all aspects of safety reporting processes.
  • System Knowledge: Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and Standard Operating Procedures (SOPs).
  • Project Oversight: Oversee assigned projects to ensure compliance with ICON, sponsor, and regulatory timelines for safety reporting.
  • Ownership: Take lead responsibility for safety reporting activities on assigned projects, ensuring accuracy and compliance with ICON standards and client obligations.
  • Collaboration: Build and maintain relationships with project team members, clients, investigators, and vendors.
  • Database Management: Maintain timely updates to project information and safety reporting databases.
  • Documentation: Ensure proper filing and quality control of documents in the eTMF or agreed filing solutions for audits and inspections.
  • SOP Development: Assist in developing departmental SOPs and work procedures.

Requirements

  • Education: Bachelor’s degree in life sciences.
  • Experience: 4 to 6 years in a similar role within pharmacovigilance.
  • Language Skills: Fluency in English.

Benefits of Working at ICON

At ICON, we believe that our success is rooted in the quality of our people. We are committed to fostering a continuous learning culture where you can develop your skills and grow your career.

Our competitive total reward package includes:

  • Competitive Salary: Regularly benchmarked to industry standards.
  • Comprehensive Benefits: Including health insurance, retirement planning, and life assurance.
  • Employee Assistance Program: 24/7 access to a global network of professionals for support.
  • Work-Life Balance: Flexible benefits tailored to your needs, such as childcare vouchers, gym memberships, and more.

Commitment to Diversity

ICON is an equal opportunity and inclusive employer. We are 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 or to perform essential job functions, please let us know.

Interested in the Role?

If you're excited about this opportunity but feel you may not meet every requirement, we encourage you to apply. You may be exactly what we’re looking for!

Current ICON Employees: Please click here to apply.

Join us at ICON and help shape the future of clinical development!