Safety Associate

IQVIADurham, NC
Hybrid

About The Position

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Requirements

  • High School Diploma or equivalent
  • Scientific or healthcare discipline or allied life sciences background with 1-1.5 years of relevant experience.
  • Good knowledge of medical terminology.
  • Working knowledge of applicable Safety Database (ARGUS).
  • Good working knowledge of Microsoft Office and web-based applications.
  • Ability to multi-task, manage competing priorities and deadlines.
  • Willingness and aptitude to learn new skills across Safety service lines.
  • Ability to work as a Team Player, contribute and work towards achieving Team goals.

Responsibilities

  • Prioritize and complete the assigned trainings on time.
  • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • 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.
  • 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.
  • Mentor new teams members, if assigned by the Manager.
  • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
  • Ensure quality of deliverables according to the agreed terms.
  • Use of telephone and face-to-face communication requiring accurate perception of speech.

Benefits

  • Health and welfare benefits
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