Skip Navigation
Search Jobs

Job Match 0Saved Jobs

Medical Sciences Opportunities at Parexel

Medical Sciences

Drug Safety Associate

Job ID 53829BR Shenyang Wobu, Liaoning, China
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

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

Sign Up for Alerts

Get the latest Parexel career opportunities as soon as they become available.

Recently Viewed Jobs

You have not recently viewed any jobs

View all jobs

RECRUITMENT FRAUD ALERT

It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.