Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.
End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.
Post Graduate Diploma in Clinical Trials or equivalent with at least 60% marks. At least one-year experience in clinical research. Experience in recruiting patients in clinical trials, familiarity with good documentation practices and good clinical practices.
Ability to conceptualize and drive large-scale marketing strategies with an execution-first approach. Experience in leading teams, collaborating with sales, and driving prescription demand at a national level.
Perform complex scientific study data review and management of CDM, Study Responsible Scientist SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities e.g., Coding, SAE reconciliation is possible.
Bliss GVS is a fast-growing Pharmaceutical Company with a proven track record of developing, manufacturing and marketing high quality pharmaceutical formulations at affordable prices for the global market.
Diploma in Pharmacy from the Maharashtra State Board of Technical Education or a Degree in Pharmacy from a recognized University. Preference will be given to those with a degree in Pharmacy. Comprehensive Thalassemia Care, Pediatric Hematology Cancer and Bone Marrow Transplantation Center
BPharm, BSc, MPharm, MSc, MBBS, BAMS; Experience in PV/ Clinical Research drug safety preferred. Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.
Coordinating with cross-functional teams for data collection and dossier preparation. Handling regulatory queries and responses from global health authorities. Ensuring compliance with ICH guidelines, USFDA, EDQM, and other international regulatory standards