Synergen Bio Private Limited is a DCGI(CDSCO) approved new age CRO with all necessary infrastructure to cater to the Pharmaceutical and Biotech industry, established by a group of enthusiastic professionalswith a vision to set-up a premium Clinical Research Organization known for its Quality, Knowledge and Expertise. Synergen Bio understands the importance of quality clinical research services and our significantly experienced team strives to provide the same to our sponsors at significant cost advantages. Representing a vertically integrated CRO, we offer customised solutions to suit sponsor requirements for the full spectrum of clinical research.
Post : Sr.Research Associate
Department : PB (Project Management and Bio-Pharmaceutics)
Qualification : MSC, B.Pharm, M.Pharm
Experience : 02 to 04+ year’s
No Vacancy : 02
Note : Immediate joiner preferred
Job Location : Shivajinagar, Wakadewadi Pune.
Tasks Responsibilities :
Preparation of Clinical Study Reports (CSR) for EMEA, WHO, SAHPRA. TGA, US- FDA, Costa Rica, others regulatory and Appendices and formats as per projects
Proficient in e-CTD (both new and paper to e-CTD) Scan, bookmark, hyperlink, optimization, fast-web view apply inherit zoom, and create Table of Contents (TOC) for PDFs
Preparation of regulatory summary reports for different regulatory BTIF (for WHO), SAHPRA (for South Africa), BSIF (for TGA), DBE (for US-FDA), FOREBI (for Costa Rica) and m 2.7.1 Presentation of Biopharmaceutical and Bioanaiytical data (for MHRA, EMEA, NPRA- Malaysia and ROW)
Knowledge of SDTM, particularly related to BABE studies.
Resolving queries from regulatory.
Interested Candidate Share CV on careers@synergenbio.com
Last Date : 20th September 2024
