Our client brings together Pharmacovigilance expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets.
Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible and scalable, developed using advanced technologies that enable us 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 be 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.
Numbers & Facts
Location
Jersey City, New Jersey
Website
https://www.ydtsglobal.com
Skills
Biotech and Pharmaceuticalunmatched
Cross-Functionalunmatched
Data Miningunmatched
Database Administrationunmatched
Interpersonal Skillsunmatched
Maintain Complianceunmatched
Medical Affairsunmatched
Medical Dictionary for Regulatory Activities (MedDRA)unmatched
Multitaskingunmatched
Oracle Applicationsunmatched
Performance Metricsunmatched
Pharmacovigilanceunmatched
Regulationsunmatched
Requirements Managementunmatched
Risk Managementunmatched
SAP BusinessObjectsunmatched
Safety Systemsunmatched
Scalable System Developmentunmatched
System Validationunmatched
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