Job title: Drug Safety Medical reviewer
Job description: Job Title Drug Safety Medical reviewer Overall Purpose of the Job Responsible for medical review and assessment of Adverse Events, within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard ope
Job Title Drug Safety Medical reviewer Overall Purpose of the Job Responsible for medical review and assessment of Adverse Events, within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs Responsibilites/Authorities Major Accountability: Review and verify appropriate selection of adverse events from source documents and appropriate MedDRA codes Review labeling and assess company causality Review narrative and provide company comment in accordance with client requirements. Verify consistency between the source documents and the narrative summary, if needed. Acquire and maintain current knowledge of product portfolio and safety profiles of products across therapeutic areas Identify, escalate and resolve case issues, co-ordinate with client therapeutic team/site for specific products or functional groups Communicate and interact effectively within the team and with the client Ensure Follow up for cases where required Perform other drug safety related activities as assigned Plan, organize, and manage daily work to meet service level timelines and deliverables Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and Client policies. Work with the SDL/Designee to escalate issues or tasks outside the normal scope of work. 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 23:54:50 GMT
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