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1-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Pharmacist

Location:

Hyderabad, India

Experience Required:

1 – 2 years


Qualifications & Specifics

Education:

  • B. Pharmacy / M. Pharm

Preferred Skills:

  • Data Integrity

  • Knowledge of Standard Operating Procedures (SOPs)

  • Technical and Scientific knowledge

  • Regulatory awareness

  • Reporting and updating

  • Commitment to continuing education


Detailed Responsibilities:

  • Receive and store Investigational Medicinal Products (IMPs)

  • Coordinate with PI to request randomization schedule from the biostatistician

  • Dispense various dosage forms of IMPs

  • Maintain IMPs accountability

  • Perform retention, return, or destruction of IMPs

  • Review IMP documentation for accuracy, completeness, and compliance

  • Manage the pharmacy according to SOPs and GMP

  • Request and receive study-specific documents from QA

  • Ensure calibration and maintenance of equipment (Humidity Chamber, Cold Chamber, Laminar Air Flow, etc.)

  • Compile Trial Master File (TMF) prior to the study

  • Ensure Clinical Pharmacology Units (CPUs) readiness with HK staff

  • Raise indents for required study materials/supplies

  • Verify completion of protocol training

  • Report eligible volunteers for study admission

  • Deliver ICD presentations to volunteer groups

  • Oversee admission, discharge, meal distribution, and monitoring of study subjects

  • Supervise CRTs, RNs, and other staff during clinical study execution

  • Compile and review study data for compliance with SOPs and protocols

  • Submit ICDs, CRFs, TMFs to QC and QA and address observations

  • Assist in archiving study documents

  • Report and document SOP/protocol deviations

  • Ensure compliance and data integrity during study execution