SYNGENE Career Opportunities: Junior Manager – Pharmacist (Clinical Trials) Apply Now
Designation: Junior Manager – Clinical Trial Management
Job Location: Bangalore
Department: Clinical Trial Management
About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
Job Purpose: Preparation of protocol specific pharmacy plan & secondary labeling plan. Receipt, verification & storage of Investigational Medicinal Product (IMP)
Key Responsibilities:
Preparation of protocol specific pharmacy plan & secondary labeling plan
Receipt, verification & storage of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) as per the protocol requirement and pharmacy plan at Syngene Clinical Supply Unit (SCSU)
Preparation of documents related to and performing labeling/relabeling (expiry extension & secondary labeling) of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) as per approved plan at Syngene Clinical Supply Unit
Supply & resupply of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) to investigational sites from Syngene Clinical Supply Unit as per the required temperature
Preparation of shipment documents, planning, distributing & maintaining sufficient quantity of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) at investigational sites
Perform the inventory management of Investigational Medicinal Product and Non-clinical supplies during the study and maintain related documentation
Arrange return/recall and perform reconciliation of Investigational Medicinal Product and Non-clinical supplies from site to Syngene Clinical Supply Unit
Witness destruction of Investigational Medicinal Product / Non-Clinical Supplies as per approved pharmacy plan
Maintain and ensure all clinical supply management activities are in compliance with applicable ICH-GCP, local regulatory requirements and SOPs
Ensure periodic maintenance and calibration of Syngene Clinical Supply Unit instrumentation as per applicable SOPs
Educational Qualification: B. Pharm/M. Pharm
Technical/functional Skills:
Preparation of protocol specific pharmacy plan & secondary labeling plan
Receipt, verification & storage of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS)
Preparation of documents related to and performing labeling/relabelling
Job knowledge and needs to work according to the requirement
Experience: 9-12 years
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