Job Location: Hyderabad/Secunderabad
Job Description
Position Name: Senior Technical Analyst Safety
Experience: 10+ Years
Location: Hyderabad (Hybrid)
Notice Period Immediate/Currently serving NP OR who can join within 1Month
Company AG Technologies
Required Skills
• Extensive experience working in an IT Technical Analyst role with a good understanding of the SAFETY systems.
• Basic Knowledge on Product safety systems, Product risk calculators and Raw material assessments, Product safety evolution reports, safety assessment creation.
• Knowledge on Product Risk Assessment/Exposure Calculations
• Proven track record of expertise of suite of Safety solutions e.g., Document management system, CARA, Veeva Quality one, Veeva Claims & Pharmacovigilance.
• Attend CAB for any Safety GSA Changes
• Experience in compliance environments like Pharmaceutical / Health care industries and Exposure on different regulatory guidelines like 21 CFR part11, Annexure 11 and GAMP5 etc and associate CSV and documentation practices.
• Strong knowledge on data migration, DB extraction, DB operational support, data modelling and Data architecture experience
• Strong knowledge on Legacy Database Planning, architecture and integrity, availability, and performance of database systems by providing technical support and maintenance in data migration.
• Experience of working with and influencing senior stakeholders to balance business needs with IS standards and processes
• Experience in Cloud platforms e.g., AWS, GCP or Azur
Interested Candidates can send their resume at nikita.belhekar@ag-technologies.com
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