Vineet Singh

WORK HISTORY

EDUCATION

SKILLS

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