Assistant Vice President Resume

SUMMARY

A highly analytical and detail - oriented technical leader with overall 16 years of IT experience including 12 years of experience in the pharmacovigilance domain. Expert in managing cross-functional teams to assess business processes and lead companywide technical implementations. A visionary, mentor, and target-driven professional with a knack for driving efficiency.
Wide range of experience in Pharmacovigilance domain and PV regulatory compliance
Expert in implementation of Argus/J Safety suite for case processing, periodic and expedited reports submissions (CIOMs, MedWatch, and E2B)
Extensive experience in E2B reporting to the regulatory authorities (PMDA, FDA, and EMA)
Create ad hoc reports to support compliance, case processing vendor oversight and health authority inspections/audits
Spearhead implementation of various global projects including automation of case intake process and safety systems
Act as the primary liaison between GPV system team and multiple vendors to coordinate delivery, maintenance of computing infrastructure and upgrade of MedDRA and WHO Drug Dictionary
Manage and ensure all validation documents including validation plans, OQ, PQ, IQ and validation summary are in place and meets audit standards
Successfully fulfill auditors request by delivering details on systems flows, data flows and provide systems demos
Partner with cross functional teams to identify the areas of improvement and implementation of solutions via automation
Lead CRP for the finalization of business configuration for safety system
Manage requirements gathering processes and development efforts to ensure the voice of the end-user is implemented in the product
Mentor Quality Assurance team in developing the system testing and UAT test plans/test script to ensure testing is in line with the requirements
Develop training programs for cross functional teams to improve the system and domain knowledge
Provide regular project health updates to stakeholders via weekly status meeting

AREAS OF EXPERTISE

Safety system Implementation
Application/Technical support
Change Control Management
Cross-Functional Team Leadership
Project Management
Data Migration
End-User Training
Pre-Sales support
Business Analysis
Business process design
Vendor management

PROFESSIONAL EXPERIENCE

Confidential

Assistant Vice President

Responsibilities:

Redesign the testing process by introducing a preliminary build acceptance cycle resulting in a reduced number of defects during UAT and improved quality of audit documentation
Spearhead the implementation of CFR part 11 compliance-based reporting module
Lead meetings with business owners to identify and prioritize business requirements to improve the efficiency of the case intake process
Proactively manage changes in project scope and identifying potential crises to ensure project timelines are met

Confidential

Manager Safety System

Responsibilities:

Improve the case processing vendor oversight by developing daily, weekly and ad-hoc reports resulting in increased efficiency of the case processing vendor
Transform the data entry process of structured AE source documents by automation resulting in efficiency improvement of data entry workflow
Orchestrate the migration of the Japanese AE from existing safety system to Argus Safety system via re-engineering of previously submitted PMDA E2B reports
Create system operational procedure and guidelines for system and business team
Assess and implement the Transform PV over Argus 8.0.2 upgrade for E2B R3 submission to meet regulatory deadline with no impact on the current business operations
Responsible for tracking all managed service tickets and ensuring timely and adequate follow-ups from the support vendor

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship