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 outputsSetting up folders in relevant document management systemsWorking within defined document standardsRendering final PDF documentsLoading published reports into document repositoriesAssist in maintaining the global periodic report schedule, including :
Schedule updatesQuality checksGenerating alerts and reminders for stakeholdersGenerating metricsManage 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 systemsExperience in document editing and formatting (Word, PDF), fixing document errors, and working with templatesExperience with quality documentation practices, data accuracy, and attention to detailGood communication skills with fluency in English, both written and oralPrior experience in the Pharmaceutical IndustryAbility to prioritize and manage multiple demands and projects within deadlinesGood presentation skills for imparting technical trainings when neededSkills Required
Data Analysis, Regulatory Compliance, Risk Assessment, Technical Writing, Project Management