Pharmacovigilance Assistant II

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.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Pharmacovigilance Assistant II/Senior PV Assistant - Hybrid Working - Warsaw, Poland

The Pharmacovigilance Assistant II performs a variety of administrative tasks to support the business and the project management within Pharmacovigilance and Safety Reporting, including but not limited to:Distribution of incoming safety notificationsSubmitting, filing and tracking of safety related informationWorking with the business and the Project Manager to ensure that tasks and projects are completed in accordance with SOPs, Project Specific Procedures, regulatory requirements and contract and client expectations/processes

Recognize, exemplify, and adhere to ICONs values which centers around our commitment to People, Clients and Performance.As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.

Business Support:• Trains and mentors less experienced team members.• Performs regular checks of the afterhours pager/cell phone and the SAE and PEP hotlines, as assigned.• Works independently under general supervision, delivers on assigned tasks or as a member of an ongoing project (including but not limited to Case Intake and Query Management in the Safety Database).• Develops project specific technical and planning documents in own functional area.• Able to lead and mentor other team members.• Resolves recurring issues and problems pertaining to assigned tasks and develops recommendations for management resolution.• Coordinates monthly metrics and provides to the Project Manager.• Tracking of Request for proposals (RFPs) and new awards, including sending out new awards notifications.• Generates monthly time reports for individuals/projects and running late timesheet reports for departments each week.• Book in of cases into safety database as required.• Analyze report maintenance for Safety Reporting Team.Project Management Support:• Regularly meets timelines/quality and cost expectations for a given task/project.• Resolves recurring issues and problems and develops recommendations for management resolution.• Quality control of TMF/eTMF files upon request• Assistance with audit schedules and arrangements, including preparation of documents.• Support Qualified Person for Pharmacovigilance, including PSMF activities as required.• Handling requests for literature and articles

Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.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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