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    Pv Operations Specialist I

    Iqvia
    2-5 years years
    upto 7.5 LPA
    Bengaluru
    10 July 17, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    PV Operations Specialist 1

    Location: Bengaluru, India
    Job Type: Full time
    Job ID: R1430787

     

    Job Overview:

    Review, assess, and process safety data and information across service lines received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

     

    Essential Functions:

    • Prioritize and complete assigned trainings on time.
    • Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
    • Perform pharmacovigilance activities, including:
      • Collecting and tracking incoming adverse events (AE)/endpoint information.
      • Determining initial/update status of incoming events.
      • Database entry.
      • Coding AEs and products, writing narratives, and handling literature-related activities as per internal/project timelines.
    • Ensure quality standards and productivity meet project requirements.
    • Ensure compliance with all project-related processes and activities.
    • Read and acknowledge all necessary IQVIA and customer SOPs as required. Ensure all required training is executed timely and documented.
    • Create, maintain, and track cases as applicable to the project plan.
    • Identify quality problems and bring them to the attention of a senior team member.
    • Demonstrate problem-solving capabilities.
    • Liaise with different functional team members (e.g., project management, clinical, data management) and healthcare professionals (e.g., investigators, medical monitors, site coordinators) to address project-related issues.
    • May liaise with clients regarding day-to-day case processing activities.
    • Mentor new team members if assigned by the Manager.
    • Attend project team meetings and provide feedback to the operations manager on any challenges/issues or successes.
    • Perform other duties as assigned.
    • Lead/support department initiatives.
    • Ensure 100% compliance with all people practices and processes.
    • Depending on project requirements, perform medical review of non-serious AEs and non-serious adverse drug reactions (ADRs), including:
      • Reviewing AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical information.
      • Ensuring completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines.
      • Communicating with team leads for any corrections required in the case and maintaining appropriate documentation for all communications.

     

    Qualifications:

    • 2-5 years of relevant experience in pharmacovigilance case processing.
    • Bachelor's degree in Pharmacy, Life Sciences, or related field.
    • Good knowledge of medical terminology.
    • Intermediate working knowledge of applicable safety database and any other internal/client applications.
    • Knowledge of applicable global, regional, and local clinical research regulatory requirements.
    • Excellent attention to detail and accuracy.
    • High-quality standards.
    • Good working knowledge of Microsoft Office and web-based applications.
    • Strong organizational and time management skills.
    • Strong verbal/written communication skills.
    • Self-motivated and flexible.
    • Ability to follow instructions/guidelines, utilize initiative, and work independently.
    • Ability to multi-task, meet strict deadlines, manage competing priorities, and changing demands.
    • Ability to delegate to less experienced team members.
    • Flexibility and receptiveness to changing process demands.
    • Willingness and aptitude to learn new skills across safety service lines.
    • Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients.
    • Ability to work as a team player, contribute, and work towards achieving team goals.
    • Ensure quality of deliverables according to agreed terms.
    • Demonstration of IQVIA core values while performing daily tasks.
    • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
    • Regular sitting for extended periods.
    • May require occasional travel.
    • Flexibility to operate in shifts.

     

    About IQVIA:
    IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at IQVIA Jobs.

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