Operations Specialist

IQVIA (Jakarta JK, Indonesia) 21 days ago

Responsibilities:

  • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/ endpoint information.
  • Determining initial/update status of incoming events.
  • Database entry.
  • Coding AE and Products, writing narratives, literature related activities as per internal/ project timelines.
  • Ensure to meet quality standards per project requirements.
  • Ensure to meet productivity and delivery standards per project requirements.
  • To ensure compliance to all project related processes and activities.
  • Prioritize and complete the assigned training on time.
  • Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
  • Creating, maintaining and tracking cases as applicable to the project plan.
  • Identify quality problems, if any, and bring them to the attention of a senior team member.
  • To demonstrate problem solving capabilities.
  • Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
  • May liaise with client in relation to details on day to day case processing activities.
  • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
  • To mentor new team members, if assigned by the Manager.
  • Lead/ support department initiatives.
  • Perform other duties as assigned.

Requirements:

  • Degree in Life Science/ Healthcare discipline.
  • Good knowledge of medical terminology.
  • Knowledge of applicable global, regional, local clinical research regulatory requirements will be an advantage.
  • Strong organizational skills and time management skills.
  • Strong verbal/written communication skills. 
  • Excellent attention to detail and accuracy, ensuring 100% compliance towards all people practices and processes.
  • Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
  • Ability to be flexible and receptive to changing process demands.
  • Willingness and aptitude to learn new skills across Safety service lines. 
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Operations Specialist

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