Maharashtra

TCS combines tech expertise and business intelligence to catalyze change and deliver results. Our mission is to help customers achieve their business objectives by providing innovative, best-in-class consulting, IT solutions and services and to make it a joy for all stakeholders to work with us. Clinical Data, Regulatory, Clinical Operations, Pharmacovigilance; Should be open to work In shifts

Postgraduate, Graduate degree in Science Eg. B.Pharm, Life Science, B.Sc., Biotech, Zoology, Botany, etc. with Diploma in Clinical Research is mandatory. One year experience in clinical trial monitoring is desirable.

research experience and knowledge in theoretical or computational biophysics, biophysical chemistry, protein dynamics, molecular dynamics simulations; Candidate should be familiar with enhanced sampling methods and MATLAB coding. Site-Specific Mechanism Of Aberrant Inter-Molecular Self-Assembly Of Full-Length TDP-43 In Neurodegeneration

Required Trial Coordinator under Resonance Research Capacity Building; Post Graduation in Science M.Pharm, Life Sciences, Biotech, Zoology, Botany, etc. with PG Diploma in Clinical Research is mandatory. The Tata Memorial Centre, TMC is a Comprehensive Cancer Centre with a mission to achieve the highest standards in patient care, cancer prevention, cancer research and professional development for oncology and allied disciplines.

Looking for clinical Database Developer experience in eCRF build and edit checks build in Veeva studio; Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process. Providing support for the mapping and transformation of clinical data to CDISC SDTM standards. Work independently and accountable for study Data Management deliverables; Coordinate with Biostatistician, Clinical, Medical and local study team as applicable

Experience working with Pharma-API plant. Responsible for adherence to SOP’s, to meet production targets, maintain safety practices. Able to handle and analyse process problems in manufacturing. Sound knowledge of operations of centrifuge, reactors etc.

Preparation of regulatory monitor and market intelligence data. Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.

Preparation and submission of post approval variations and send proper communication for implementation of the change. Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.

Assess the performance of external manufacturing partners, identify opportunities for improvement. Ongoing performance tracking for external manufacturing, including quality, cost, delivery, and efficiency. Ensure the alignment of external sites with Teva expectations