Safety Intake Coordinator

At Proclinical, we are seeking an individual to fill the role of Safety Intake Coordinator, based in Foster City, CA.

Responsibilities

• Appropriately intake, triage and disseminate information related to potential adverse events.
• Responsible for submission support duties including updating the safety database and ensuring that submissions are made to the correct agencies.
• Perform simple queries of the safety database.
• May perform initial data entry of ICSRs.
• May interpret case-related information.
• Meet specific data and quality targets for case handling
• Responsible for regulatory submissions of ICSR and aggregate reports.
• Track and reconcile incoming adverse event reports, Investigator letter distribution, and regulatory submissions.
• Coordinate submission of product complaints to the Quality assurance department.
• Assist Safety Specialists in sending and tracking follow-up letters.
• Remain current with case handling SOPs, guidance documents and database technology.
• Ensure compliance with SDEA and other global regulatory reporting requirements.
• May assist in the preparation of training material, as well as training new employees.

Skills And Qualifications

• BS degree or equivalent experience in health, clinical, biopharmaceutical or other relevant industry.
• Safety database and data entry experience preferred.
• Basic understanding of medical and drug terminology preferred.
• Experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations preferred.
• Strong proficiency in Microsoft Office.
• Excellent written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kathleen McGurk at (+1) 2674358600 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.