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