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Pharmacovigilance Reporting Associate (French/German Language)

0-4 years
Not Disclosed
10 Oct. 3, 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

Pharmacovigilance Reporting Associate (French/German Language)

Company: ICON plc
Location: [Specify Location]

ICON plc is a leading healthcare intelligence and clinical research organization committed to innovation and excellence. We foster an inclusive environment and invite you to join us on our mission to shape the future of clinical development.

Role Overview:

The Pharmacovigilance (PV) Reporting Associate is responsible for processing safety reporting intelligence and may lead stand-alone safety reporting projects while providing management support as needed. This role focuses on Medical Information activities and requires interaction with the public and healthcare professionals.

Key Responsibilities:

  • Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) according to assigned tasks and project-specific procedures.
  • Conduct adverse event follow-ups in writing and/or via phone based on client requirements.
  • Review abstracts and full articles to identify safety information from literature sources for both pre- and post-marketed products.
  • Generate data listings from the safety database and ensure data accuracy.
  • Provide input and review safety tracking systems for quality and accuracy; assist in maintaining project files.
  • Conduct safety reviews of clinical and diagnostic data as part of case processing.
  • Develop and implement the Safety Management Plan, ensuring consistency within the project.
  • Support post-marketing safety activities, such as PSMF, RMP, and PBRER.
  • Assist the Qualified Person for Pharmacovigilance as required.
  • Liaise with investigational sites, reporters, and sponsors regarding safety issues.
  • Collaborate with ICON Medical Monitors, project managers, and other departments as needed.

Requirements:

  • Background or education in healthcare (Nursing, Pharmacy, Medicine).
  • Fluency in English and either German or French.
  • Strong communication skills.

What ICON Offers You:

At ICON, our success hinges on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a comprehensive range of benefits focused on well-being and work-life balance for you and your family, including:

  • Various annual leave entitlements
  • Flexible health insurance options to suit your family’s needs
  • Competitive retirement planning to help you save for the future
  • Global Employee Assistance Program, LifeWorks, providing 24-hour access to over 80,000 independent professionals for support
  • Life assurance
  • Optional country-specific benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments

Visit our careers site to learn more about the benefits ICON offers.

Equal Opportunity Employer:

ICON is committed to creating a workplace free from discrimination and harassment. We encourage applications from all qualified individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require reasonable accommodation during the application process or to perform essential job functions due to a medical condition or disability, please let us know or submit a request.

Interested in the Role?

If you’re interested in this position but unsure if you meet all the requirements, we encourage you to apply. You may be exactly what we’re looking for, whether for this role or others at ICON.