Job title: Drug Safety Associate (Data Analyst)
Job description: Job Title : Drug Safety Associate Overall Purpose of the Job Responsible for the processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events within agreed timeframes and to a high standard of accuracy, in compliance with c
Job Title : Drug Safety Associate Overall Purpose of the Job Responsible for the processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events within agreed timeframes and to a high standard of accuracy, in compliance with client’s, standard operating procedures and global regulatory requirements. Responsibilities/Authorities Major responsibilities: Perform triage including prioritization of cases Perform duplicate search in AA Create a case (Initial/FU) in AA. Update the daily tracking spreadsheet to be exchanged with the Asia CO. Enter the mandatory fields in AA Upload the Source document in AA Receive feedback from the QC associate and make corrections as per feedback (for mentees). Make necessary corrections when applicable Upload the ESP Source Document Transcription/Translation Quality Control Form in AA following completion of corrections. Create follow-up action item. Route the case to Core Successfully complete and clear proficiency test in client data base Affiliate. Key performance indicators: Ability to learn quickly. Number, timeliness and scientific quality of deliverables according to established directives Consistent demonstration of company values/behaviours. Ensure that Post Marketing Adverse Events are evaluated accurately and within the required timeframes to meet regulatory requirements Requirements A Bachelor’s degree in a science-related field, pharmacy, nursing, registered dental, or equivalent; HCP qualification required. Preferred, but not required: A minimum of 1 year clinical experience, or its equivalent, in Pharmacovigilance, hospital or pharmacy; familiarity with clinical assessment an advantage HCP education qualification ( Pharmacist, Bachelor of Dentistry/ Physiotherapy/Nursing, MBBS, MD) Benefits PF
Location: Bangalore, Karnataka
Job date: Sat, 29 Jan 2022 23:44:49 GMT
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