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
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.
Knowledge of the Life Sciences Industry and life cycle of drug.
Relevant product and industry knowledge.
Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross department communication.
Ability to document and communicate problem/resolution and information/action plans.
The ability to contribute to a team environment with a high degree of professionalism and skill.
Demonstrate flexibility within a dynamic, fast-paced, cross-functional team.
Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
Ability to perform under stringent timelines.
Awareness of organizational policies & procedures governing his/her job responsibilities.
Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level.
Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions : Normal office environment.
Standard Hours 40 hours per week, one-hour lunch, Monday Friday.
Additional hours as needed.
Willing to work in shifts as and when needed
Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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