Senior Pharmacovigilance Associate

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.

Senior Pharmacovigilance Associate - Hybrid Working - Sofia, Bulgaria

Performs case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically- related project information, such as adverse events of special interest, clinical endpoints and medical information inquiries, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.

Responsibilities:

• Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing of safety events and medical information inquiries• Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors• In collaboration with Data Management, reconciles SAEs between clinical and safety databases.

For ICON Strategic Solutions, may also include:•Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated.•Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.•Demonstrate skills pertaining to client management, safety reporting intelligence, project scope, submission compliance, quality, and budget as designated.• Perform or Supervise periodic reconciliation of adverse event and/or quality  complaint cases within the required deadlines.•Submits safety reports to licensing partners of ICON PRA clients.• Coding Adverse Events in accordance to the applicable standard dictionary • Perform or supervise quality complaint activities for assigned projects, including monitoring of returning samples for quality compliant and applicable tracking • Quality Control of activity as applicable

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.