Senior Pharmacovigilance Systems Specialist
4 weeks ago
About our client:
Our client is a leading provider of pharmacovigilance solutions, leveraging advanced technologies to develop agile, flexible, and scalable systems that address challenges across Medical Affairs, Regulatory, and Safety functions.
Their solutions enable pharmaceutical companies to free up responsible personnel, execute their stated responsibilities, and achieve a balance between compliance and managing business risks.
Our client is committed to advancing patient outcomes and bringing focus to things that really matter.
Their solutions are designed to serve large and small organizations, both in developed and emerging markets.
Requirements
JOB DESCRIPTION
Experience: 12-18 Years
Location:
East Coast, United States
Employment :
Full Time
Role and Responsibilities:
Should have excellent functional knowledge of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
Should have experience in installing/configuration/validation of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
Should attend all meetings as a PV Systems subject matter expert (SME).
Should participate in and contribute to safety system design requirement specifications for the safety database as a PV Systems SME.
Should provide vendor/client oversight of report development: Compliance, Aggregate, Signal Detection, Data Mining, Key Performance Indicators (KPIs).Should be able to review and provide feedback on templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions.
Should be able to 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.
Should be primary lead for deliverables and participate in audits and inspections of the dedicated PV System.Should have solid understanding of pharmacovigilance principles and practices.
Behavioral 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 objects.-
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