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Technical Associate - Consumer Safety Global Operations

0-5 years
Not Disclosed
12 May 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Technical Assistant (TA) - Safety Documentation Management

Position Purpose: The TA is responsible for assisting with the management of aggregate reports and other safety documentation, including generating safety database outputs, managing mailboxes, and performing other support activities.

Responsibilities:

  • Provide technical support in the preparation of aggregate periodic reports, including but not limited to:

    • Safety Risk Management Plans
    • Periodic Benefit Risk Evaluation Reports
    • Responses to PRAC assessment reports
    • Developmental Safety Update Reports
    • Medical Device Periodic Safety Update Reports
    • Cosmetic Undesirable Effects Reports
    • Canadian Annual Reports
    • US Periodic Adverse Drug Experience Reports
    • Clinical Overviews and Summaries
  • Perform technical support tasks such as:

    • Generating safety database outputs
    • Setting up folders in relevant document management systems
    • Working within defined document standards
    • Rendering final PDF documents
    • Loading published reports into document repositories
  • Assist in maintaining the global periodic report schedule, including:

    • Schedule updates
    • Quality checks
    • Generating alerts and reminders for stakeholders
    • Generating metrics
  • Manage and triage assigned group mailboxes within Consumer Safety.

  • Provide access to and maintain oversight of shared areas, distribution groups, and Team Sites.

  • Undertake an expert role in records management as needed.

  • Serve as an administrator in document management systems as needed.

  • Contribute to process improvement activities specific to record management, archiving, and periodic report scheduling.

Minimum Requirements:

  • Excellent computer skills, including proficiency in Word, Excel, Internet/Intranet, and document management systems
  • Experience in document editing and formatting (Word, PDF), fixing document errors, and working with templates
  • Experience with quality documentation practices, data accuracy, and attention to detail
  • Good communication skills with fluency in English, both written and oral
  • Prior experience in the Pharmaceutical Industry
  • Ability to prioritize and manage multiple demands and projects within deadlines
  • Good presentation skills for imparting technical trainings when needed

Diversity, Equity, and Inclusion: At Haleon, we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We strive to generate curiosity and promote fair and equitable outcomes for everyone. Our goal is to create a climate where diversity is celebrated, respect is mutual, viewpoints are valued, communities are supported, and authenticity thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore the opportunities with our hiring team.

Application Process: Care to join us? Find out what life at Haleon is really like at www.haleon.com/careers.

Equal Opportunity Statement: Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.

US Transparency Requirements: If you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses incurred on your behalf for interview-related activities to ensure compliance with federal and state US Transparency requirements. Your information will be treated confidentially.