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 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.
As an Aggregate Report, Medical Assessment Specialist Coordinate all internal and external PSUR activities to be carried out by Bioclinica aggregate reporting team Maintain PSUR calendar for each client Prepare and distribute aggregate report as per client requirement As a Lead / Project Manager Act as a management level liaison between Client and Bioclinica Project team Coordinate and manage administrative project issues Delegate tasks and responsibilities to appropriate personnel Identify and resolve issues and conflicts within the project team Recruit, select and train team members Act as guide, coach and counselor for the team 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. Communication skills : 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 departmental communication.
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.
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. Compliance : 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. 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