Ref #: 28891

Employment type: Permanent - Full-Time

Location: US-TN-Nashville

Posted: 30-Apr-2021

Description

DOCS is currently seeking an experienced Drug Safety Specialist for an exciting opportunity based in Brentwood, TN.

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

Responsibilities:
-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.

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

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997,

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.