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Marketed Product Safety Specialist 2 (R1036966) in Dublin 18, Ireland at IQVIA™

Date Posted: 1/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/13/2019
  • Job ID:
    R1036966

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.

RESPONSIBILITIES

  • Work closely with project teams to determine appropriate terms and conditions of safety agreements
  • Develop and prepare safety agreements
  • Prepare and maintain PSMFs
  • Review PSMFs prepared by other specialists
  • Primary customer interface on large, complex projects, responsible for developing and maintaining customer
  • relationships
  • Provide input to project plans to accurately reflect services provided. Oversee finalization and distribution of safety agreements
  • Assist in the negotiation of safety agreement text using approved processes and templates.
  • Represent safety agreements team at customer meetings as required
  • Provide input into project budgets involving safety agreements.
  • Provide advice, support and guidance to other staff involved in preparing safety agreements.
  • Mentor and train team members
  • May assume the responsibilities of EU QPPV or deputy QPPV as outlined in Quintiles Work Instruction: CS_WI_LS0013 Lifecycle Safety-Qualified Persons for Pharmacovigilance (QPPV)
  • Perform all other duties as assigned

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Excellent knowledge of Lifecycle Safety processes
  • Excellent attention to detail and accuracy and maintain consistently high quality standards.
  • Excellent written and verbal communication skills.
  • Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time manage competing priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree or educational equivalent in health science or other directly related field and a minimum of 3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience or equivalent combination of education, training or experience.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1036966