Principal Consultant

6+ years experience in Pharmacovigilence domain. Worked as Implementation/Validation consultant of Safety products using PL/SQL scripts following CSV processes

• Change-Request-Management
• computer system validation
• Gute Herstellungspraxis (GMP)
• Requirement Analyse
• Testing (IT)

A highly motivated and dedicated professional with 6.5 years of experience in services of Life Science Safety
system applications. Known for Implementation and configuration of Safety applications as per customer
specific requirements. Having a strong knowledge in implementing, configuring, testing, and upgrading
safety systems following GxP, GAMP, CSV and 21CFRPart11 guidelines. A proactive problem-solver with
excellent communication and interpersonal skills, fostering positive working relationships and delivering
best results and eager to contribute my expertise to make a meaningful impact in this field.

ArisGlobal Safety applications:
LSMV, ARISg, ESM, CCM, EVTriage, Bizlink, Alerts, Business object, Mendelson

Processes
Pharmacovigilance, Computer System Validation, GxP, GAMP E2B R2/R3, 21CFR Part11, EUAnnex11

Documentation:
Validation Plan, Configuration Specification Configuration verfication, User Testing,
Software Validation & Verification, Functional Specifications, User Requirements, Test case documentation,IQP/OQP IQ, OQ, PQ IQSR/OQSR, VSR/PSR, Requirement tracebility matrix

Primary Skills:
Manual Testing, PL/SQL, Postgre, Oracle, SQL, JavaScript(basics)

Testing Tools
HP ALM, Procedure Capture, JIRA

Others
SVN, SharePoint, GitHub