ACPRU Investigational Pharmacist
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
ACPRU Investigational Pharmacist ensures that the investigational product (IP) is received stored compounded/dispensed and accounted for in the conduct of ACPRU clinical studies per the clinical study randomization schedule and dose preparation instructions. The Investigational Pharmacist through appropriate application of USP DEA and GCP requirements generates SOPs and Work Instructions for ACPRU pharmacy operations.
Responsibilities
Full supervisory responsibility for all pharmacy staff and equipment
Maintain accurate drug accountability: Ensures IP-related clinical trial records including the receipt preparation retention samples dispensing and return of IP are maintained per USP DEA and GCP requirements. Ensure compliance to randomization schedule for blinded studies responsible for verification of study set up. Ensure all pharmacy materials are available and of the appropriate quality and quantity throughout the execution of every study.
Coordinates ordering use and handling of ancillary supplies (e.g. rental pumps infusion sets IV fluids) for quality oversight and management in the conduct of clinical trials
Subject matter expert for quality audits and regulatory inspections conducted at ACPRU
Subject Matter Expert for SOPs Work Instructions and Business Process documents pertaining to
ACPRU pharmacy operations including procedures concerning quality assurance security of controlled substances and disposal of hazardous waste and drugs
Review protocols and provide input on study-specific materials and activities that impact investigational product and ACPRU workflow in relation to compounding and dispensing. Contribute to the development of Dose Preparation Instructions and associated study records/templates. Including collaboration with Pharma Science and Device Development throughout all phases (0-4) of development at global sites.
Ensure compliance with federal and state laws regulations and policies governing pharmacy operations
Effectively communicates with ACPRU staff AbbVie Management and external vendors
Point of contact to support AbbVie related efforts to improved clinical study execution as it related to compounded study drug preparation throughout all phases of development at global sites
Qualifications :
- Experience: BS in Pharmacy w/ 7 year; MS or equivalent w/ 5 years; PharmD w/ 2 years
- Illinois Licensed Pharmacist
- Demonstrated ability to learn understand and master experimental techniques
- Ability to multitask and work within aggressive timelines
- Ability to focus on the future and anticipate pharmacy operation needs
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
