Senior Pharmacovigilance Associate

As a Senior Pharmacovigilance Assoiate  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Perform 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.
  • 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

You are:

• Professional
• 3-4 years of experience
• Good English skills

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.