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Job Information

Pfizer Controlled Substance Coordinator in Lake Forest, Illinois

Why Patients Need You

A career with us is about discovering breakthroughs that change patients' lives. A high performing administrative team is essential to bringing those therapies to people all over the world and making a positive difference. We need dedicated colleagues like you who are efficient, find solutions and collaborate with others to achieve our purpose.

What You Will Achieve

The Controlled Substance Coordinator will receive and perform daily work assignments from the Manager, Site Controlled Substances. The Controlled Substance Coordinator will be primarily responsible for data entry into computation charts, destruction spreadsheets, physical inventory reports, and ARCOS reports. The Controlled Substance Coordinator will also be responsible for filling in for absent Site Controlled Substance Managers, keeping Management aware of any issues and all other tasks deemed necessary by Management. The Controlled Substance Coordinator will assist the Controlled Substance Managers during DEA inspections and will be expected to coordinate with a pre-determined inspection team in the Manager's absence.

Continued compliance with DEA and state regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.

How You Will Achieve It

  • Maintenance of Controlled Substance Accountability Tracking Systems: Accurate and timely data collection and entry by product, for API, WIP, FG, samples, and rejects.

  • Collection, entry, and review of data for preparing waste shipment records, including ensuring accurate inventories by verifying quantities against primary source documents.

  • ARCOS Reporting: Data review and entry of ARCOS transactional information on a monthly basis for purchases and shipments, and annual reporting for inventory and sample transactions.

  • Participate in the site Biennial Inventory: Data consolidation and sortation of physical count sheets into reportable formats for reconciliation.

  • Inspection Readiness Support for internal audits and DEA inspections: Regularly reviewing primary source documents for appropriate DEA required information, including but not limited to DEA forms, receiving paperwork, shipping paperwork, internal transfer records, batch records, Disposal reports, Inventory Cards, Sales reports, and Dispensing reports. Support audit requests and coordination activities.

  • Assist with controlled substance import and export preparatory work, including submitting appropriate documents to the DEA for declarations and permits.

  • Assist Manager with DEA inspections or internal audits of controlled substances and coordinates a response with site inspection team in the Manager's absence.

  • Assist with the development and implementation of training materials and procedural documents, including but not limited to: Diversion awareness, CDA training, Controlled Substance handling, Year-End Inventory, etc.

  • Field questions during Manager absences and escalate to above site management.

Qualifications

Must-Have

  • Minimum High School Diploma or Equivalent.

  • Minimum of 1-3 years of related industry experience.

  • Must have strong organizational skills and be detail oriented.

  • Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook).

  • Strong oral and written communication skills.

Nice-to-Have

  • Experience working in pharmaceutical industry.

  • Some knowledge of DEA regulations.

  • SAP knowledge.

  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.

  • Regulatory experience.

PHYSICAL/MENTAL REQUIREMENTS

Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders.

Work Location Assignment:On Premise

Last Date to Apply: February 7, 2023

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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