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Pharmacovigilance Reporting Associate (French/German Language)

0-4 years
Not Disclosed
10 Oct. 3, 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 Associate (French/German Language)

Company: ICON plc
Location: [Specify Location]

At ICON plc, we are a leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. We invite you to join us on our mission to shape the future of clinical development.

Role Overview:

The Pharmacovigilance (PV) Reporting Associate will serve as a safety reporting intelligence processor and may lead stand-alone safety reporting projects, providing designated management support. This role focuses on safety reporting activities with a customer-centric approach and an audit-ready mindset, primarily involving Medical Information tasks, including communication 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 follow-ups for adverse events in writing and/or by 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 the accuracy of the data.
  • Provide input and review relevant 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 the creation of post-marketing safety activities, including 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:

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

What ICON Offers You:

Our success relies on the quality of our people, and we prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON provides a comprehensive range of benefits focused on well-being and work-life balance, including:

  • Various annual leave entitlements
  • Flexible health insurance options tailored to your family's needs
  • Competitive retirement planning to help you save for the future
  • Global Employee Assistance Program, LifeWorks, offering 24/7 access to a network of over 80,000 independent professionals for support
  • Life assurance
  • Country-specific optional benefits such as 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 maintaining a workplace free of discrimination and harassment. We provide equal consideration for employment to all qualified applicants regardless of 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 are unsure whether you meet all the requirements, we encourage you to apply. You might be exactly what we’re looking for, whether for this role or others at ICON.