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Product Safety Associate, Contract

3 months ago

Columbia, South Carolina, United States Connect Life Sciences Full time

Contract Product Safety Associate, Remote

Responsibilities to include but not limited to the following:

  • for monitoring inbound mailboxes and/or other inbound systems for safety reports for multiple clients and projects
  • maintenance of adverse event files and documentation
  • administrative support, including data entry, correspondence, filing, ensuring adherence to study protocols and internal SOPs, and providing other administrative support to the team, as needed
  • receipt and initial data entry steps in compliance with agreed upon timelines
  • author narratives for safety events of low complexity with oversight from more senior team members
  • interface with site personnel in support of the Product Safety Leads
  • participate in reconciliation activities.
  • cross-functionally on multiple projects in compliance with mandatory timelines
  • safety-related study start-up and/or close-out activities, including creation and management of safety-related study plans
  • electronic files of assigned work in an audit/inspection ready state
  • in the review and development of SOPs, guidelines, and/or work instructions to support case processing activities
  • with internal team and/or investigative clinical research sites to support compliance with safety processes
  • areas for process improvements
  • excellent customer service to internal and external clients in a timely and professional manner
  • initiative to complete project-specific responsibilities
  • the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • excellent customer service to internal and external clients in a timely and professional manner
  • to email and other communication requests in a timely fashion using a variety of methods including but not limited to email, instant messaging, and other communication tools
  • to maintain confidentiality

Takes initiative to complete project-specific responsibilities with minimal supervision

Other duties as assigned

Required Skills/Abilities/Competencies:

  • to work effectively and collaboratively within a team environment
  • judgment and decision-making skills
  • to interact with health care professionals
  • to work in a fast-paced, dynamic environment
  • to adapt well under pressure
  • to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
  • verbal and written communication skills, including the ability to communicate effectively through email
  • in the use of business productivity software (Excel, Word, PowerPoint, etc.)
  • with global regulatory requirements for pharmacovigilance is a plus
  • with end-to-end case management is a plus
  • with safety database applications and MedDRA/WHO Drug coding is a plus

Education and Experience:

  • degree (preferably in a health science related field); Associates degree AND 3-5 years LPN experience may be considered in lieu of an RN or a Bachelor's degree
  • utilizing a product safety database, Argus preferred