Operations Specialist ( pharmacovigilance)

Job content

Sub Family Description

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.

Job Profile summary

• To Prioritize and complete the assigned trainings on time.
  • 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.
  • Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
  • 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.
  • To 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.
  • Perform other duties as assigned.

Experience

• Bachelor’s degree in life sciences or related field and upto 3 years of relevant experience, inclusive of upto 1 year of Pharmacovigilance experience; or equivalent combination of education, training and experience

Knowledge

• Good knowledge of medical terminology
  • Working knowledge of applicable Safety Database and any other internal/Client applications.
  • Knowledge of applicable global, regional, local clinical research regulatory requirements
  • Excellent attention to detail and accuracy; maintain high quality standards
  • Good working knowledge of Microsoft Office and web-based applications
  • Strong organizational skills 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
  • 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 communication and working relationships with coworkers, managers and clients
  • Ability to work as a Team Player, contribute and work towards achieving Team goals
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  • Ensure quality of deliverables according to the agreed terms
  • Demonstration of IQVIA core values while doing daily tasks

Skills and Abilities

• Extensive use of keyboard requiring repetitive motion of fingers.
  •Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.