Associate Drug Safety Team Lead

Bioclinica India Private Limited (Mysore, KA, India) 4 days ago

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

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