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Lifesphere Multivigilance Business Analyst
3 months ago
Position: Life sphere Multi vigilance Business Analyst
Location: Thousand Oaks, CA
Duration: Long Term Contract
JOB DESCRIPTION:
- Excellent functional knowledge of pharmacovigilance (PV) Systems like Lifesphere Multivigilance etc.
- Attend all meetings as a pharmacovigilance Systems subject matter expert (SME).
- Participate in and contribute to safety system design requirement specifications for the safety database as a PV Systems SME.
- Provide vendor/client oversight of report development: Compliance, Aggregate, Signal Detection, Data Mining, Key Performance Indicators (KPIs).
- Review and provide feedback on templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions.
- Review and provide feedback on work instructions associated with ongoing safety database maintenance projects, including upgrades, Medical Dictionary for Regulatory Activities (MedDRA) / WHO Drug versioning, direct Electronic Submission Gateway (ESG) setup, etc.
- Primary lead for deliverables and participate in audits and inspections of the dedicated drug Safety System.
- Solid understanding of pharmacovigilance principles and practices.
Behavioural Skills:
- Ability to multi-task, self-directed and independently handle multiple global stakeholders.
- Ability and willingness to be flexible, adapting to the demands of the customers.
- Exceptional interpersonal skills to interact with a variety of stakeholders and foster cross-functional/cultural teamwork.
- Ability to work in a fast-paced environment, maintaining flexibility and performing at a high level when faced with time constraints.
- Strong critical thinking skills to evaluate alternatives and present solutions consistent with business objective
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