Ref #: 33588

Employment type: Permanent - Full-Time

Location: US-TN-Brentwood, TN

Posted: 08-Nov-2021


ICON is currently seeking a Drug Safety Specialist based in Brentwood, TN. We are open to backgrounds in healthcare and pharmacy (pharmacy technicians).

We have a very well established pharmaceutical client looking for people who have some experience in the pharmaceutical industry who would want to work in the Pharmacovigilance/Drug Safety area. Responsibilities relate to Inbox Management and Case Receipt, Case Registration and Confirmation, and Case Follow-Up

-Electronically track all cases and source documents received to ensure information to be captured is not missed and the appropriate Day 0 is recorded
-Verify in accordance with company Procedure Documents for the accuracy and completeness of all source documents received
-Ensure the minimum information is present for all cases as identified in company Procedure Documents
-For all ICSRs received, identify and query critical missing information to register the case (e.g. country of reporter or occurrence, missing clock start date, missing company product)
-Perform a duplicate check to determine if a report is duplicate, initial or follow up to an existing report
-If non-valid due to the missing valid case criteria, the report should still be registered in the Global Safety Database
-Complete case registration in accordance with applicable with company Procedure Document
-Register all cases in the Global Safety Database within 2 business days of receipt
-Confirm case receipt/acknowledgement (based on company SOPs and/or Process Documents) for digital and non-digital cases.
- Request additional information to cases followed up by the company if an assessment is deemed necessary for medical evaluation of the case outside of standard queries
-Assist with follow-up activities based on medical review queries in accordance with company Procedure Documents
-Perform follow-up for all applicable cases and document in the Global Safety Database in accordance with company Procedure Documents
-Monitor and review outstanding follow-up query action items for applicable cases within the Global Safety Database
-The method of querying will be in accordance with company Procedure Documents. This may include fax, email or electronically through Global Safety Database, if applicable/available.

-Bachelors Degree
-Minimum of 2 years of experience in drug safety with AE and SAE reporting experience

Benefits of Working in ICON:
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.

At 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.

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, 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