Clinical Data Specialist

4 dni temu

Warszawa, Mazovia, Polska ICON plc Pełny etat

At ICON plc, a world-leading healthcare intelligence and clinical research organization, we're seeking a highly skilled Pharmacovigilance Assistant to join our dynamic team in Warsaw.

This role plays a vital part in supporting the collection, documentation, and reporting of safety data related to medications and clinical trials. As a Pharmacovigilance Assistant at ICON, you will ensure compliance with regulatory requirements, contributing to patient safety and the ongoing success of clinical research programs.

Your Key Responsibilities:

  • Data Collection and Management: Support the collection, review, and processing of adverse event reports related to clinical trials and marketed products.
  • Database Maintenance: Ensure timely and accurate data entry of safety information into pharmacovigilance databases.
  • Reporting and Compliance: Assist in the preparation and submission of safety reports to regulatory authorities and sponsors, as required.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams to maintain compliance with safety regulations and company protocols.
  • Documentation and Record-Keeping: Maintain detailed records and documentation related to pharmacovigilance activities and safety reporting.

About You:

  • Bachelor's degree in life sciences, pharmacy, or a related field is preferred.
  • An understanding of pharmacovigilance principles and regulatory requirements is an advantage.
  • Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently.
  • Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting.
  • Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols.
  • The role is office-based (with option of 2 days at home). This is not negotiable.

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