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ICON Clinical Research Senior Pharmacovigilance Assistant in Warsaw, Poland

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

Senior Pharmacovigilance Assistant - Hybrid Working - Poland

The Senior Pharmacovigilance Assistant performs a variety of more complex administrative tasks to support the business and the project management within Pharmacovigilance and Safety Reporting, including but not limited to:

• Distribution of incoming safety notifications

• Submitting, filing and tracking of safety related information

• Preparation, organization and maintenance of files, reports, listings and similar

• Preparation of audits, meetings for the management

• Working with the business and the project manager to ensure that task and projects are completed in accordance with SOPs, contract, and client expectations/processes.

• Support Qualified Person for Pharmacovigilance, including PSMF activities as required.

• Lead administrative support activities for projects and programs.

• Provide back-up support to the Administration Supervisor/Manager

• Functioning as an SME for Pharmacovigilance processes and/or systems.

Training and mentoring of new/more junior members of the global administration team.

Business Support:

Provides phone coverage for medical staff for routing of backup coverage for projects.

Performs systems checks for the afterhours coverage system (checks on cell phone, and the SAE and PEP hotlines), to ensure accurate performance; maintain after hours binder of all current project information as per internal SOPs/Working Instructions

Actively monitors quality and quantity of the administrative work, appropriately addresses issues with the team and the management.

Coordinates special projects, at the request of management, which may include:

  • planning and coordinating administrative services

  • creating and maintaining documentation tools

  • supporting the development and improvement of processes

  • supporting the development and improvement of systems (including but not limited to participation in UAT and Dry Run Activities)

  • Coordinates and assigns workload cross regional within the team.

  • Maintains knowledge of filing structure and classification; decides or escalates questions and issues as appropriate.

  • Applies excellent and advanced knowledge in all areas of the job role.

  • Has advanced experience in leading, training and mentoring other team members.

  • Resolves and/or develops recommendations for issues and problems having broad impact.

  • Tracking of Request for proposals (RFPs) and new awards, including sending out new awards notifications

  • Reports: Timesheets, headcount, utilization and project specific time logging reports

  • Maintenance/assistance with local BCP

  • Provide back-up support to Admin Supervisors/Manager as required.

  • Lead Administrative support activities for projects, initiatives, process and system improvements

Project Management Support

  • Able to work independently and efficiently

  • Highly skilled in simultaneously handling multiple tasks.

  • Undertakes fact finding to define issues.

  • Gathers information from a variety of different sources for use by Project Manager.

  • Displays a strong initiative in carrying out assignments.

  • Contributes to reports for internal and external parties.

  • Organizes effectively to achieve greater results.

  • Develops clear and concise schedules and communicates to both internal and external project team members.

  • Proactive in identifying risks or issues on project.

  • Capable of handling more challenging tasks.

  • In-depth task management skills.

  • Able to effectively mentor and train colleagues.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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