Hiring for Hiring MBBS / MD&#039 s for Medical Reviewer Position in Mysore, for Exp. 0 - 2 yrs at Boiclinica India Pvt Ltd.

  • Esteemed client of Orion TrueTech Services India
  • Mysore, Karnataka, India
  • Apr 03, 2019
Full time Pharma, Healthcare & Biotechnology Jobs

Job Description

Job Description:Bioclinica is hiring MBBS / MD' s &amp amp nbsp freshers for Medical Reviewer Job Title : Drug Safety Physician (Medical Reviewer) Location : Mysore / Bangalore Years of Experience : 0-2 years in Pharmacovigilance Education : Should be a qualified MBBS/MD (in any discipline) Essential Duties and Responsibilities: As a Medical Reviewer Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion Perform triage of cases and determine seriousness and relatedness across products as assigned Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas Escalate complex case issues on client product(s) to the medical review team of the client as appropriate Conduct assessment of litigation cases across products as assigned&amp amp nbsp Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate Acquire and maintain knowledge of applicable Global Health Authority regulations Perform any other drug safety related activities as assigned. Specialized Knowledge and Skills: Experience with relevant safety databases and related software applications Proven experience in customer handling and relationship. Proven ability to perform task management. Proven people management skills. Must have good presentation skills and the ability to give presentations.&amp amp nbsp Knowledge of the Life Sciences Industry and life cycle of drug. Relevant product and industry knowledge. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills.&amp amp nbsp Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross department communication.&amp amp nbsp Ability to document and communicate problem/resolution and information/action plans. Other skills: The ability to contribute to a team environment with a high degree of professionalism and skill.&amp amp nbsp Demonstrate flexibility within a dynamic, fast-paced, cross-functional team.&amp amp nbsp Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.&amp amp nbsp Ability to perform under stringent timelines. Compliance: Awareness of organizational policies &amp amp amp procedures governing his/her job responsibilities.&amp amp nbsp Awareness and compliance of QMS &amp amp amp ISMS policies &amp amp amp procedures and their impact at his/her job level.&amp amp nbsp Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS &amp amp amp ISMS policies and procedures. Working Conditions : Normal office environment. Hours : Standard Hours 40 hours per week, one-hour lunch, Monday Friday. Additional hours as needed. Willing to work in shifts as and when needed