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Sr Medical Safety Physician

1.00 to 3.00 Years   Mysore   27 May, 2020
Synowledge
Job LocationMysore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

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 assigned.

    As an Aggregate Report, Medical Assessment Specialist

  • 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

  • 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

    • ,

    Keyskills :
    peoplemanagementskills stronginterpersonalskills lifecycle drugsafety lifesciences globalhealth medicalreview adverseevents teammanagement clinicaltrials peoplemanagement managementskills productportfolio customerhandling therapeuticareas

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