PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Drug Safety Associate
Essential 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
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
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• 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
Candidate Profile
• 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
• 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
Additional Information:
Location: Chandigarh
Functional Area: Pharmacovigilance
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 16th February, 2018
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