Drug Safety Associate-I

Drug Safety Associate-I

Parexel International (India) Pvt. Ltd.
Not Specified
Not Specified

Job Description



Basic Function: Responsible for capturing and assessing single adverse event reports associated with client products on the client's Drug Safety database, in accordance with international and local regulatory requirements

Principal Functional Responsibilities:
. Determining the category of information received i.e. whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
. Creating/generating AE/Product Complaint forms in the Product Complaint System
. Keeping track of the Product Quality Complaints
. Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions/guidelines and Standard Operating ProceduresQualifications

Basic Function: Responsible for capturing and assessing single adverse event reports associated with client products on the client's Drug Safety database, in accordance with international and local regulatory requirements

Principal Functional Responsibilities:
. Determining the category of information received i.e. whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
. Creating/generating AE/Product Complaint forms in the Product Complaint System
. Keeping track of the Product Quality Complaints
. Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions/guidelines and Standard Operating Procedures

Job Details

Employment Types:

Industry:

We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Job Source : jobs.parexel.com

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