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Pharmacovigilance Assistant

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Location:
Poland; Bulgaria, Warsaw

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

We are currently seeking an Administrative Assistant to join our diverse and dynamic Pharmacovigilance team. As part of the Pharmacovigilance team at ICON you will play a vital role in providing administrative support on global projects. Your attention to detail will be essential in supporting the organization’s commitment to patient safety and compliance. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

Job Responsibility:

  • Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes
  • Provide administrative support to project teams as required
  • Distribute reports to Sponsors, sites, and applicable ICON personnel
  • Coordinate setup of required systems and mailboxes during study startup
  • File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF
  • Maintain data entry for safety event and miscellaneous tracking logs for all current projects
  • Assist with organization and planning of meetings
  • Daily entry into, and maintenance of, appropriate tracking systems
  • Maintain project training records for all assigned project team members
  • Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees
  • Updating and maintenance of project database information systems
  • Perform regular testing of fax numbers and e-mail addresses as required
  • Maintenance, coordination and updates of shared and validated documentation repositories
  • Coordination of translation of documents for projects
  • Completion of monthly metrics
  • Handling requests for literature and articles
  • Assistance with audit schedules and arrangement
  • Assist with generation/distribution of project specific procedures

Requirements:

  • Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry)
  • Basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential
  • 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
  • Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint)
  • Fluent in written and verbal English
  • Ability to work effectively independently and within a team environment and across global teams

Nice to have:

  • Experience in office administration, customer service, or assisting roles
  • A background in medical or biological sciences
What we offer:
  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, LifeWorks
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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