Drug Safety Associate

Drug Safety Associate

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 Procedures
. Reviewing ancillary documentation accompanying the reports and identifying the relevant information for processing and electronic capture in the applicable database
. Maintaining an excellent knowledge of case processing conventions and guidelines, client's procedures and international drug safety regulations
. Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents
. Ensuring MedDRA coding in accordance with 'MedDRA Term Selection: Points to Consider', where applicable
. Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs
. Responding to clients/customers in a timely manner
. Performing triage of literature abstracts and/or full articles for validity, if required
. Performing single case creation/initiation in the safety database, if required
. Mentoring new recruits in the team, if required
. Identifying areas of concern within the team and raising the issues with the Team Lead
. Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits
Qualifications and Experience:
. Science/Medicine degree: The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage
. Good knowledge of medical terminology
. Fluency in written and spoken English, Japanese, Chinese
. Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)
. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
. Ability to evaluate data and draw conclusions independently
. Typing and transcription accuracy
. Team player

Job Details

Employment Types:


Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

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