Pharmacovigilance Associate/Senior Associate

hace 3 semanas


Xico, México Icon Plc A tiempo completo

At ICON plc, we are seeking highly skilled Pharmacovigilance Associates and Senior Associates to join our Pharmacovigilance Safety & Reporting group.

Responsibilities:

Safety:

  • Process all types of safety events, medical information call handling activities, and other medically related project information.
  • Reconcile SAEs, literature surveillance, and data retrievals from the safety database, supporting the generation of aggregated safety reports and Data Monitoring Committees (DMC) reviews.
  • Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
  • Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

Reporting:

  • Submit expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings, and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, Partners, and ICON personnel, if required, and as agreed with client during study set-up, within project specified timelines.
  • Release safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures.
  • Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
  • Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.

Requirements:

We are looking for individuals with a strong understanding of pharmacovigilance principles, regulations, and guidelines. The ideal candidate will have excellent communication and analytical skills, with the ability to work in a fast-paced environment and meet deadlines.

What We Offer:

At ICON plc, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.



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