Vineet Singh
Vice President at Prudentia Group
- Role
- Vice President at Prudentia Group
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Vineet Singh
Good knowledge of Pharmaceutical Safety Systems which includes E2B Regulations (EMEA/FDA/MHLW etc), ICSR’s, Safety Applications and Database Development/ Implementation/ Maintenance and Validation and Support. Blend of very good Technical and functional knowledge in Pharmaceutical domain- Knowledgeable on the ICH guidelines governing the global reporting of adverse events- Defining Business Requirements- Work as a Business analyst in Project and capture the customer business process and requirments- Experience with validation of ARISg (or related Drug Safety systems) and affiliated modules (e.g, IRT, OST, ESM)- Assisted the clients in the preparation of the aggregate safety reports such as Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR)- Planning and Executing IQ/OQ/PQ- Preparing TM, Risk mitigation plan for project- Project management- Resource Management- Providing end to end support and maintenance of Safety system- Experience in maintenance/upgrade of the ARISg safety database, including participation in validation and implementation activities for system upgrades- Expertise in MedDRA dictionary with relevance to adverse event coding- Conducted sessions with business users (PV users) to execute user acceptance testing and training- Provided internal trainings on drug safety applications, regulatory applications,clinical research and trails- Provide functional oversight for projects and provide project management expertise where required- Interacting with clients primarily in US and Europe providing them with technical and functional knowledge, support, Product training
Experience
Vice President
Jan 2023 — Present · NJ, US
Education
Oxford College of Engineering, BANGALORE
Master of Computer Applications - MCA
Skills
- Resource Management
- 21 Cfr Part 11
- Agile Methodologies
- Testing
- Test Planning
- Sdlc
- Ich-Gcp
- Oracle
- Requirements Analysis
- Regulatory Submissions
- Arisg/J
- Pharmacovigilance
- Business Analysis
- Pl/Sql
- Xml
- Sql
- Business Process
- Databases
- Computer System Validation
- Software Project Management
- Unix
- E2b
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