Drug Safety Operations Manager
4d ago
source :

Drug Safety Operations Manager Mysore India Essential Duties and Responsibilities As an Associate Project Manager Supervision and coordination of following activities Lead and manage the project to comply with the SOW and SLAs Supervise all project related activities Single point of contact between the team and the client for smooth functioning of the project Communicate between the management and the team Record maintain and track the metrics for both team members and project performance Review and evaluate AE case information to determine required action based on and following internal policies and procedures Process current incoming cases in order to meet timelines Provide guidance for Data entry Following up with sites regarding outstanding queries Follow up on reconciliation discrepancies Follow departmental AE workflow procedures Train and mentor new team members as per requirements of the project 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 Other responsibilities Other responsibilities Following up with sites regarding outstanding queries and reconciliation of discrepancies Closure and deletion of cases Follow departmental AE workflow procedures Oversee mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates High level of proficiency at all workflow tasks Perform any other drug safety related activities as assigned Specialized Knowledge and Skills Subject Matter Expertise in Safety database 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 a plus Experience in entire drug development life cycle Relevant product and industry knowledge Experience with relevant safety databases and software applications 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 department communication Ability to document and communicate problem resolution and information action plans Technical skills Person should be familiar with MS Office tools Data base and other applicable software Ability to educate train the team members as needed Contributing to the ongoing enhancement of Pharmacovigilance process and SOP s including internal and external training Maintaining Pharmacovigilance systems including global safety database Other Skills The ability to contribute to a team environment with a high degree of professionalism and skill Demonstrated 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 working conditions Normal office environment

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