Essential Duties and Responsibilities : As a Team Lead : Supervision and coordination of following activities : Lead and manage the projects Supervise all project related activities.
Communicate between the Project Manager 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.
Delegate tasks and responsibilities to appropriate personnel Identify and resolve issues and conflicts within the project team Act as guide, coach and counselor for the team 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 Years of Experience : 3 to 4 Years of industry related experience Education : MBBS / MD or B pharm / M pharm / MBA Experience : More than 3 years of experience in Pharmacovigilance / Pharmaceutical / Clinical research professional.
Specialized Knowledge and Skills : Subject Matter Expertise in Safety database 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. 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.
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