Technical Associate - Consumer Safety Global Operations

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