ICON Clinical Research Medical Administration Assistant in Warsaw, Poland

  • The role - German language skills desired*

Maintain efficient and accurate daily work flow and tracking of documents and information within Pharmacovigilance and Safety Services Department. Ensure required documentation is sent to Sponsor companies in accordance with Standard Operating Procedures, Project Specific Procedures, and Regulatory Timeframes. Provide administrative support to departmental staff as required. Departmental responsibilities may require support to PV & Safety Services and Regulatory Reporting teams

  • Responsibilities*

· Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.

· Distribute safety reports to Sponsors, sites, and applicable ICON personnel in accordance with Standard Operating Procedures and Project Specific Procedures*

· 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 (room planning, set-up, and attendee logistics), including preparation and distribution of presentations, agendas, and meeting minutes, as requested*

· Daily entry into, and maintenance of, appropriate tracking systems (e.g. SAE/safety event tracking systems)

· Answer SAE Hot Line, and other departmental phone lines as necessary; document contacts and submit to appropriate personnel

· Perform archiving activities and as required

· Updating and maintenance of project information systems*

· Perform regular testing of fax numbers and e-mail addresses

· Maintenance, coordination and updates of eRooms

· Coordination of translation of documents for projects

· Generation of monthly Planview/Timesheet reports for individuals and projects, including authorisations and data entry for new projects

· Tracking of RFP’s and New Awards and distribution of information to relevant teams

· Completion of expense reports for PV & Safety Services staff

· Completion of monthly metrics

· Handling requests for literature and articles

· Coding of invoices in invoicing system and submission for approval

· Assist with generation/distribution of project specific procedures

· Attend project team and Sponsor meetings and teleconferences as required

· Responsibility for preparation, global tracking and coordinating of REG submission documents sent by courier

  • Requirements*

· High school diploma or local equivalent**

· No pharmacovigilance experience required

· Excellent computer skills (Microsoft Word, Excel, Outlook, Access)

· Familiarity with standard office equipment

· Excellent communication skills

· Detail-oriented

· Fluent in written and verbal English

· German fluency desired

· Excellent organizational skills

· Knowledge of medical terminology (basic)

· Ability to work effectively independently and within a team environment