Job Title: Pharmacist – Clinical Trial Supply Management
Company: Syngene International Ltd.
Location: Bangalore, Karnataka, India
Department: Biometrics
Division: Discovery Services
Job Type: Full-Time
Experience Required: 2–5 Years of Experience in Clinical Trial Pharmacy, Investigational Product (IP) Management, or Clinical Supply Management
About Syngene International
Syngene International Ltd., established in 1993, is a globally recognized contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries.
The company partners with global industry leaders including Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. With a strong team of scientists and research professionals, Syngene supports global partners by accelerating drug discovery, enhancing research productivity, and reducing development timelines through innovative scientific solutions.
Role Overview
The Pharmacist – Clinical Trial Supply Management plays a critical role in managing Investigational Medicinal Products (IMP) and non-clinical supplies used in clinical trials. This role is responsible for ensuring the proper receipt, storage, labeling, distribution, and reconciliation of clinical trial supplies while maintaining strict compliance with ICH-GCP guidelines, regulatory requirements, and internal Standard Operating Procedures (SOPs).
The position requires strong knowledge of clinical trial pharmacy operations, investigational product handling, and supply chain management within clinical research environments.
Key Responsibilities
Clinical Trial Supply Planning
Prepare protocol-specific pharmacy plans and secondary labeling plans for clinical trial supplies.
Ensure pharmacy operations align with clinical trial protocols and regulatory guidelines.
Investigational Product Management
Receive, verify, and store Investigational Medicinal Products (IMP) and Non-Clinical Supplies (NCS) according to protocol requirements and pharmacy management plans.
Maintain appropriate storage conditions and temperature control for clinical trial supplies.
Labeling and Documentation
Prepare documentation for labeling and relabeling activities including expiry extension and secondary labeling of clinical trial supplies.
Perform labeling and relabeling activities in accordance with approved pharmacy plans.
Clinical Supply Distribution
Manage supply and resupply of Investigational Medicinal Products and Non-Clinical Supplies to investigational sites.
Ensure distribution and transportation of clinical trial supplies under appropriate temperature-controlled conditions.
Shipment and Logistics Management
Prepare shipment documentation and manage logistics for distributing clinical trial supplies to study sites.
Ensure adequate supply of Investigational Medicinal Products is maintained at investigational sites.
Inventory Management
Maintain inventory records for Investigational Medicinal Products and Non-Clinical Supplies throughout the study lifecycle.
Track stock levels, maintain documentation, and ensure accurate reconciliation of supplies.
Product Return and Reconciliation
Coordinate return or recall of Investigational Medicinal Products from study sites.
Perform reconciliation and documentation of returned clinical trial supplies.
Product Destruction Oversight
Witness and document destruction of Investigational Medicinal Products and Non-Clinical Supplies as per approved pharmacy plans.
Compliance and Quality Assurance
Ensure all clinical supply management activities comply with ICH-GCP guidelines, local regulatory requirements, and company SOPs.
Support internal and external audits related to clinical trial supply management.
Equipment Maintenance
Ensure periodic maintenance and calibration of equipment used in the Syngene Clinical Supply Unit in accordance with applicable SOPs.
Educational Qualifications
Master’s Degree in Life Sciences or Master’s Degree in Pharmacology.
Experience Requirements
2–5 years of experience in clinical trial pharmacy, investigational product management, or clinical supply management.
Experience in handling clinical trial supplies and regulatory documentation is preferred.
Technical Skills
Strong understanding of ICH-GCP guidelines and Indian regulatory requirements related to clinical trials.
Knowledge of investigational product handling, labeling, and distribution processes.
Experience with clinical trial documentation and pharmacy-related SOP development.
Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.
Audit and Compliance Knowledge
Experience supporting internal and external regulatory audits.
Strong understanding of compliance standards in clinical supply chain management.
Behavioral Competencies
Strong attention to detail and organizational skills.
Excellent written and verbal communication skills in English.
High level of integrity and commitment to compliance and quality standards.
Ability to manage multiple responsibilities within a clinical research environment.
Equal Opportunity Employer
Syngene International Ltd. is committed to providing equal employment opportunities to all qualified individuals regardless of race, gender, religion, nationality, disability, or other protected characteristics. The company promotes diversity, inclusion, and fair employment practices and provides reasonable accommodations for individuals with disabilities.
Job Location
Bangalore, Karnataka, India.
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