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Technical Associate - Consumer Safety Global Operations

Technical Associate - Consumer Safety Global Operations

ConfidentialHyderabad / Secunderabad, Telangana
9 days ago
Job description

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
  • Skills Required

    Data Analysis, Regulatory Compliance, Risk Assessment, Technical Writing, Project Management

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    Associate Operation • Hyderabad / Secunderabad, Telangana

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