Business Transformation (BT) Expert (PV SME)
YD Talent Solutions
- Noida, Uttar Pradesh
- Permanent
- Full-time
- Experience: 8-12 Years
- Location: Noida, India
- Employment: Full Time
- 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.
- 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.