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

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