SYNGENE Career Opportunities: Junior Manager – Pharmacist (Clinical Trials) Apply Now

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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