Administrator, Pharmacovigilance

Location: Nottingham, England, United Kingdom

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Requisition Number: 2471

Position Title: Administrator, Pharmacovigilance

External Description:

SUMMARY: Responsible for general administrative duties for the Pharmacovigilance (PV) Department including assisting with delivery of PV services according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.

Primary responsibilities include:

  • Intake and triage of incoming safety information
  • Data entry/tracking
  • Preparing, performing and tracking safety submissions and trial master file submissions as directed by PV management and/or team members

RESPONSIBILITIES:

With guidance and oversight:

  • Monitor PV inbox for incoming safety information, identifying relevant study and consulting with Lead PV Associate to determine action needed
  • Perform data entry in the Safety Database and/or complete relevant tracking of incoming safety information
  • Compile, coordinate and track mail courier services as needed
  • Preparation and submission of safety documents to the trial master file
  • Provide ad-hoc administrative support for all team members of the Pharmacovigilance department
  • Work on related projects as needed; update management on status of projects
  • Ensure any unassigned emails in the PV mailbox are flagged as appropriate
  • Compose, proofread, edit and prepare correspondence, presentations and publications using Microsoft Word and PowerPoint
  • Assist with preparation or updates to global PV and/or study specific templates and documents
  • Provide administrative support to PV staff including filing and scanning of paper and electronic documents
  • Maintenance of departmental and study trackers
  • Manage translations with translation vendor for study specific documents
  • Handle confidential and sensitive matters with discretion
  • Train new staff on administrative tasks as requested
  • Perform other duties as assigned.

OTHER SKILLS AND ABILITIES:

  • Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
  • Excellent organization skills and ability to handle multiple competing priorities within tight timelines
  • Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities.
  • Ability to anticipate needs and follow through on all assigned tasks
  • Able to effectively receive and provide constructive feedback without becoming defensive
  • Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.
  • Handle confidential and sensitive matters with discretion

REQUIREMENTS:

  • Experience in operating office equipment such as fax machines, copiers and scanners
  • Excellent written and verbal communication skills
  • Strong organization skills and attention to detail
  • Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
  • Ability to work independently, prioritize work effectively and work successfully in matrix team environment
  • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
  • Fluent in written and verbal English

Preferred:

  • Previous CRO and/or Pharmacovigilance experience
  • Basic knowledge of medical terminology

#LI-HO1

City:

State: Nottinghamshire

Employment Type: Regular

Community / Marketing Title: Administrator, Pharmacovigilance

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Nottingham, GB

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