Pharmacist

Location: Hyderabad

Experience: 01 - 02

Qualifications & Other Specifics

Qualifications:

• B. Pharmacy / M. Pharm

Preferred Skills:

• Data Integrity.
• Procedural Knowledge (SOP).
• Technical & Scientific Knowledge.
• Regulatory Awareness.
• Reporting and Updating./li>
• Continouing Education.

Detailed Responsibilities:

• To receive and Storage IMPs.
• Request for randomization schedule generation from biostatistician according to protocol in coordination with PI.
• Dispensing of different dosage form of IMPs.
• Maitainance of IMPs accountability.
• To perform retention, send back or destruction of IMPs.
• Review of IMPs documents to ensure accuracy, completeness, and compliance with protocol, SOP and regulatory guidelines.
• Manage the Pharmacy according to the SOP’s. and GMP.
• Request and receipt of study specific documents from QA.
• Ensure the appropriate periodic maintenance and calibration of equipments like Humidity Chamber, Cold Chamber and Laminor Air Flow etc.
• Compilation of study specific TMF (prior to study).
• Readiness of the CPUs with the support of HK staff.
• Place indents to procure material / supplies needed for the study.
• Self-checking of protocol training completion.
• Reporting of eligible volunteer’s/subjects for study admission.
• Providing ICD presentations to volunteers in groups.
• Perform admission, discharge, meal distribution, reporting, and monitoring of subjects during the clinical study conduct.
• Supervision of activities of other study personnel (CRTs, RNs) during the conduct of clinical study.
• Compilation and review of study data and ensuring the compliance with SOPs and protocol during the study conduct.
• Compilation of study documents on timely.
• Responsible for submission of study documents (ICDs, CRFs and TMFs) to QC, QA for review and subsequent closure of observations in consultation with Study PIC/ PI or designee.
• Assist the PIC for the archiving of study documents.
• Identification of the SOP / protocol deviations and bring it to the notice of project in-charge for recording.
• Compliance and data integrity during study execution with SOPs and regulatory requirements.

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