Job type full-time
Full job description
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 assignedAs 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 knowledgeCommunication skills: requires a proactive approach and excellent written/oral communication and interpersonal skillsStrong interpersonal skills required to interact with clients, management, and peers effectivelyEffective cross‑ departmental communicationAbility to document and communicate problem/resolution and information/ action plansOther skills: the ability to contribute to a team environment with a high degree of professionalism and skillDemonstrate flexibility within a dynamic, fast-paced, cross-functional teamDemonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environmentAbility to perform under stringent timelinesCompliance: awareness of organizational policies & procedures governing his/her job responsibilitiesAwareness and compliance of qms & isms policies & procedures and their impact at his/her job levelShould understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, qms & isms policies and proceduresWorking conditions: normal office environmentHours: standard hours 40 hours per week, one-hour lunch, monday – fridayAdditional hours as neededWilling to work in shifts as and when needed
Posted 30+ days ago