Pharmacovigilance Specialist

hace 2 semanas


Xico, México Icon Plc A tiempo completo
About ICON plc

We are a world-leading healthcare intelligence and clinical research organization.

Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.

Job Title: Pharmacovigilance Specialist/Safety Intelligence Analyst

Salary: $65,000 - $85,000 per year

About the Role

As a Pharmacovigilance Specialist or Safety Intelligence Analyst with our team, you will play a key role in ensuring the safe use of medications by performing safety event processing, medical information call handling activities, and data retrievals from the safety database.

You will be responsible for reconciling SAEs, literature surveillance, and data retrievals, as well as generating aggregated safety reports and supporting Data Monitoring Committees (DMC) reviews.

You will ensure all regulatory timeframes are met for the processing and reporting of safety information, working closely with project teams and clients to deliver high-quality results.

  • Serve as a safety reporting processor and/or lead for multiple safety reporting projects, providing management support as designated.
  • Responsible for safety reporting activities on assigned projects, working in a customer-focused approach and an audit and inspection-ready mindset.
  • Coding Adverse Events in accordance with applicable standard dictionaries.
  • Serving as a quality complaint processor for assigned projects, monitoring the process of returning samples for quality compliant tracking.

In addition to your technical skills, you will also be responsible for maintaining a strong understanding of ICON's safety reporting systems, processes, and conventions.

You will operate in a lead capacity, ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.

We are looking for talented individuals who can bring their expertise and passion to this role. If you are interested in making a difference in the pharmaceutical industry, we encourage you to apply.



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