Company Name: Actavis, Inc. Import
Job Details
Duration: Permanent
Min Education: Not Specified
Salary: Commensurate
Job Type: Full Time
Min Experience: Not Specified
Required Travel:
Location:
  • USA - Ft. Lauderdale Florida, 33301
Job Description
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with all Company policies and procedures, including safety rules and regulations. Cond ucts comprehensive reviews of customer sales data to ensure suspicious customers are brought to management's attention. Analyzes pharmacy dispensed data submitted by pharmacy customers for review of overall business customers may be engaged in. Reviews Due Diligence documentation submitted to company by customers. Develops and maintains electronic system for the tracking of any and all documentation submitted or gathered regarding company's customer base. Develops a system to accurately capture information related to site visits conducted by contracted companies or company employees. Continually monitors various forms of public and private media for changes in state or federal controlled substance registration landscape. Researches current and developing regulations and attends training programs. Promotes early visibility of emerging DEA and state regulatory initiatives that impact the company, and develops proactive strategies for complaint solutions. Develops and maintains databases or timelines for internal change implementation. Administers theft and loss reporting requirements and conducts trend analysis including gathering and logging all customer reported-controlled substance discrepancies, developing reports to assess frequency and/or severity, and coordinating remediation efforts with Distribution, Security, Customer Service and Accounts Receivable. Monitors Suspicious Orders Reporting system and conducts follow-up activities related to actual incidents. Supports general compliance activities facilitated by Department. Assists DEA Compliance Managers in supporting all DEA-registered sites in matters of compliance. Establishes and maintains an electronic community for all DEA correspondence and related information associates with site activities. Provides support to sites during DEA inspections. Administers on-site visits to local customers to ensure compliance is up to Company standards. Provides designated site personnel with the tools to conduct extensive research of licensing requirements for multiple states/jurisdictions and complex coordination of expiry, submission and payment deadlines in order to avoid state violation penalties and/or suspension of licensure. Performs related duties as assigned. Knowledge of/Skill In: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. State and federal regulations relating to the manufacturing, shipping and storage of Scheduled/Controlled pharmaceutical products. Drug Enforcement Administration (DEA) regulations, Prescription Drug Marketing Act (PDMA) regulations and State Boards of Pharmacy (BOP) regulations, etc. English usage, spelling, grammar and punctuation Computer program applications such as Microsoft: Word, Excel andOutlook. Current Company policies and practices, including safety rules and regulations. Analyzing problems, identifying solutions and projecting consequences of proposed actions, and recommend and/or implement methods, procedures and/or techniques that support department goals and objectives for resolution Researching, evaluating and applying state and federal regulations relating to the manufacturing, distribution, storage and general handling of pharmaceutical products throughout supply chain. Communicating clearly and concisely, both orally and in writing. Managing and organizing multiple projects and assignments. Establishing and maintaining effective working relationships with others. Must have reliable transportation to do local site visits to customers as needed. Must have good driving record and pass DMV clearance. Must be able to work a Mon - Fri 12p-9p schedule. Bachelor's degree in related field from an accredited college or university and three (3) to five (5) years experience preferably within the pharmaceutical industry, including state regulatory experience, or equivalent combination of education and experience. Notary preferred.