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Research Pharmacist (Pharma D) @ Medanta

Job TitleResearch Pharmacist JD
Qualifications
Pharm.D. degree or equivalent. Completion of Good Clinical Practice (GCP) training within the past 2 years.
Experience
At least 3 years experience in clinical research pharmacy, preferably one supporting an early-phase, proof-of-concept operation. Experience in a good manufacturing practice (GMP), drug development in pharma or in project management with a CRO would also be beneficial.
Prerequisite Skills
  • Leadership qualities
  • Works well in a team
  • Scientific and research aptitude
  • Education and training aptitude
  • Quality management aptitude
  • Has regulatory knowledge
  • Fluent in English
Position Overview
The Research Pharmacist is the person who is responsible for all pharmacy-related operations at Medanta Duke Research Institute (MDRI). This is done under direct supervision of MDRI Director of Operations.
Other activities
In addition to the above-mentioned responsibilities, the Research Pharmacist is expected to: Initiate and participate in clinical research and other educational and training activities at MDRI. Initiate and participate in quality and process improvement activities at MDRI. Author/Train/Revise and maintain SOP’s as required
Reporting Structure
The Research Pharmacist reports to MDRI Director of Operations. The Research Pharmacist also has a ‘dotted-line’ reporting to the Project Leader for study-specific matters.
Responsibilities
  • Ensure storage, dispensing, shipment, documentation, accountability, and/or destruction when applicable, of investigational products are performed in accordance with MDRI SOPs, industry standards and sponsor instructions
  • Ensure proper supplies, storage, accountability, and security of emergency and rescue medications
  • Maintain competency in aseptic technique which includes operating laminar hoods and reconstituting investigational products according to study protocols
  • Ensure security of investigational products and controlled substances at all times not under direct visual control or manual handling
  • Ensure proper storage of all investigation and non-investigational products
  • Maintain inventories of all investigational and non-investigational products
  • Work closely with study Project Leader and study team to ensure feasibility of protocols accepted at MDRI
  • Work closely with study Project Leader and study team to assure timely supply, reconstitution, dispensing, and administration of investigational and non-investigational products, and collection of any unused products as directed by sponsor or protocol
  • Ensure study personnel is adequately informed about proper administration of investigational and non-investigational products
  • Maintain pharmacy SOPs
  • Ensure adequate maintenance of all pharmacy equipment including backups and alarm systems
  • Ensure compliance with all regulatory requirements
  • Define investigational agent needs during protocol design consultations
  • Coordinate multi-site efforts with Duke and Singapore research pharmacies
  • Liaise with hospital pharmacy for required services as needed to maintain an integrated research pharmacy services model
  • Develop and provide investigational drug product training materials to ensure proper handling, administration, documentation and disposal of investigational agents
  • Assist in the notification, tracking and documentation of all pharmacy personnel work effort and deliverables for awarded projects
  • Maximize efficiency of services through the use of automation and software tools
  • Attend regular MDRI operational meetings
  • Collaborate with research pharmacists of other Duke Proof-of-Concept (POC) units to ensure coordination and adequacy of protocol execution across the network – for multi-site protocols
Other Information
Mail your CV’s to : Dr. Savita Dhillon
Savita.dhillon@medanta.org
Please email your resumes on hr@medanta.org

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