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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 leading healthcare intelligence and clinical research organization dedicated to driving innovation and excellence in clinical development. Our mission is to shape the future of healthcare by advancing clinical research and delivering outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations. With patients at the heart of our efforts, we aim to accelerate the development of life-saving drugs and devices.

Why Join ICON?

At ICON, our people are our greatest asset. We foster an inclusive culture that encourages collaboration and innovation. We are committed to professional growth, continuous learning, and creating a supportive environment that empowers you to excel in your career.

Role Overview

As a Pharmacovigilance Reporting Specialist, you will play a critical role in ensuring the timely and accurate submission of safety reports. This includes Serious Adverse Events (SAE), periodic reports, and relevant safety information to clients, regulatory authorities, ethics committees, and other stakeholders, all while adhering to project timelines.

Key Responsibilities

  • Safety Reporting: Submit expedited SAE reports, periodic reports, and line listings to clients and regulatory bodies within specified timelines, following ICON procedures.
  • Expertise: Provide in-depth expertise on safety reporting processes, ensuring compliance with ICON’s standard operating procedures (SOPs) and relevant guidelines.
  • Project Oversight: Maintain oversight of assigned projects, ensuring all safety reporting activities meet ICON, sponsor, and regulatory deadlines.
  • Technical Support: Offer technical and process oversight for safety reporting services, ensuring accuracy and compliance with contractual obligations.
  • Collaboration: Work closely with project teams, clients, investigators, and third-party vendors to build strong relationships and facilitate effective communication.
  • Data Management: Manage multiple databases, ensuring timely updates and maintenance of project information and safety reporting data.
  • Quality Control: Ensure proper filing and quality control of documents for audits and inspections, and assist in developing departmental SOPs and work procedures.

Qualifications

  • Bachelor's degree in Life Sciences.
  • 4 to 6 years of experience in a similar pharmacovigilance role.
  • Fluency in English.

Benefits of Working at ICON

At ICON, we believe our success is driven by our talented people. We offer a competitive total reward package that includes:

  • Various annual leave entitlements.
  • Comprehensive health insurance tailored to you and your family.
  • Competitive retirement planning options to secure your financial future.
  • Global Employee Assistance Programme, LifeWorks, providing 24/7 support for your well-being.
  • Life assurance and flexible benefits, including childcare vouchers, gym memberships, and more.

Diversity and Inclusion

ICON is proud to be an equal opportunity employer, committed to creating a workplace free of discrimination and harassment. We value diversity and encourage all qualified applicants to apply, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you require a reasonable accommodation during the application process or to perform the essential functions of your role, please let us know.

Interested in Joining Us?

If you're passionate about making a difference in clinical research and believe you could be a great fit for this role, we encourage you to apply, even if you don’t meet every qualification listed. At ICON, you might be exactly what we're looking for!

Current ICON Employees

If you are a current employee, please click here to apply.

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