Highlights:- Extensive background with more than 7.5+ year's experience across various major pharmaceuticals and CROs in managing Pharmacovigilance process and handling Drug Safety systems. - Good understanding of Life Science domain with special focus on Pharmacovigilance / regulatory compliance, with good oversight of operational, maintenance and compliance of the Pharmacovigilance System. - Understanding of implementation approach and use of implementation methodology. - Experience in working with offshore team and ensuring a daily onsite-offshore interaction. - 5+ Years which includes Pharmacovigilance case processing, Project management and 3.5+ years in providing Techno/Functional consultation for various Life Sciences Technologies such as Argus Safety, AERS etc. - Has led successfully various implementation projects, very good knowledge of Oracle Argus Safety Suite and associated safety modules

Skills:Oracle Argus Safety, Pharmacovigilance, Oracle Argus Support, Argus Techno-Functional

Goal:To reach higher position, Grow with organisation.

Membership:Pharmacist Council, Maharashtra, India

Certification:1Z0-473 -Oracle Argus Safety 7 Certified Implementation Specialist Oracle Argus Enterprise Edition 7 Implementation Specialist Assessment Oracle Argus Standard Edition 7 Sales Specialist Oracle Argus Standard Edition 7 Pre-Sales Specialist Oracle Empirica Risk Management and Signal Detection 7.3 Implementation Specialist Oracle Empirica Risk Management and Signal Detection Sales Specialist Assessment Oracle Empirica Risk Management and Signal Detection Pre-Sales Specialist Assessment Oracle Argus Safety 6 Pre-Sales Specialist ITIL® Foundation Certificate in IT Service Management

Service Delivery Lead, Senior Consultant 06/2014 - current
Techsol Corporation, Hyderabad, Telangana India
Industry: Information Services
Life Sciences and Pharma IT professional with nearly 7 years experience which includes 5+ Years core experience in Pharmacovigilance practice and 2+ years in Life Sciences Technologies/ Drug Safety & Risk management & Pharma Marketing.
Project Management - Interacting with the internal / External stakeholders to understand the project status and see that task is being handled as per the Business requirement. - Understanding customer business requirements and analyzing their feasibility with respect to Life Sciences features and functionality. - Handling Implementation, Upgrade, Migration, Validation, Support and Maintenance Projects from inception till project delivery as Service delivery Lead. - Provide Operational and functional expertise on various Drug Safety applications like Oracle Argus Safety Suite, Argus Affiliate, Oracle AERS and Empirica Signal. - Requirements gathering and analysis, functional design, providing functional support to technical team as a Senior Functional consultant, working closely with customer in understanding their business process and Preparing Business Requirements Specification Document. - Configuring Argus Safety System in Validation and Production environment based on the Configuration Baseline Document (CBD). - Preparing Master validation plan (VMP) along with other Validation documents. - Configuration of Code List, Licenses, Products, Studies, User Group Creation, User creation and Accessibility, System Configuration and Workflow design. - Experience with Implementation, Validation of Axway Synchrony Gateway. - Training clients PV team as well as internal functional team on End-to-End functionality of Argus Application. - Resolving L1/L2/L3 issues related to the functionality of the application.--
Specialist, Enterprise Solutions 07/2008 - 05/2014
Sciformix Technologies Pvt Ltd, Mumbai, Maharashtra India
Industry: KPO
Life Sciences and Pharma IT professional with nearly 7 years experience which includes 5+ Years core experience in Pharmacovigilance practice and 2+ years in Life Sciences Technologies/ Drug Safety & Risk management & Pharma Marketing.
Specialties: Pharmacovigilance \ Drug Safety End to End PV Case Processing Drug Safety and Medical Information Call center handling Operations Management \ Service Delivery Clinical Research Hands on Experience in Life Sciences Applications- - Oracle Argus Safety Suite, - Oracle AERS - SCEPTRE - Axway Gateway Interchange - Empirica Signal.--

Y.B.Chavan College of Pharmacy 05/2001 - 06/2005
Aurangabad, Maharashtra, India
Degree: Bachelor's Degree
Major:Pharmacy
Bachelors in Pharmacy

Dhananjay Salunkhe Oracle Argus Safety, Pharmacovigilance, Drug Safety, Clinical Research, Pharmaceuticals