Pharmacist

4 days ago


Hyderabad Telangana, India Advity Research Full time

**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. - Providing ICD presentations to volunteers in groups. - 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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