JOB TITLE: PHARMACEUTICAL CONSULTANT

JOB CODE: 32600

DEFINITION: This is professional consultative pharmaceutical work in a Commonwealth agency.

An employee in this job administers laws and regulations related to the pharmaceutical and medical device industry for a Commonwealth agency. Work involves directing a pharmaceutical regulatory program, developing program standards, and providing technical assistance in the interpretation and application of federal and state laws, regulations, and procedures to aid with compliance. Work includes providing pharmaceutical expertise and guidance to the agency on legislation, policies, and procedures that impact programs involving pharmaceuticals and medical devices or having a pharmaceutical component; ensuring proposed pharmaceutical or medical device program changes adhere to existing federal and state regulations; and communicating with other government agencies or regulatory bodies to ensure understanding of the impacts of pharmaceutical and medical device program changes. Work is completed with considerable independence and is reviewed by an administrative supervisor for overall effectiveness and achievement of goals and objectives.

EXAMPLES OF WORK: (NOTE: The examples of work are representative of the work, but every position classified to this job may not perform all examples of work listed. Conversely, this is not an all-inclusive list of work examples.)

• Consults on pharmaceutical issues and operations such as scheduling of controlled substances, federal and state pharmaceutical regulations, record-keeping, development of drug formularies, prescription labeling, good manufacturing processes, and other pharmaceutical processes to ensure federal and state regulatory compliance.

• Analyzes and interprets current and proposed legislation to evaluate the impact to various agency programs.

• Consults with federal and state agencies to ensure consistency in the administration and regulation of pharmaceuticals and medical devices, avoidance of duplicative services, and more efficient and effective service to individuals.

• Consults and advises on legislation, regulations, and policies regarding manufacturing, distributing, and retailing of drugs, devices, cosmetics, and hearing aids.

• Coordinates with the department’s press office and other federal and state agencies to communicate and publicize changes in pharmaceutical processes that may affect agency programs and clients served.

• Coordinates with agency leadership to ensure that training is provided to staff on changes to the administration and monitoring of drugs used in agency programs.

• Assists field inspectors with difficult and critical investigations.

• Evaluates formulary designs and benefit structures and reviews clinical rationale, policy documents, and medical necessity or clinical policies.

• Performs the full range of supervisory duties.

• An employee in this job may participate in the performance of subordinates’ work consistent with operational or organizational requirements.

• Performs related work as required.

ENTRY LEVEL KNOWLEDGES, SKILLS, AND ABILITIES:

• Knowledge of the principles and practices of pharmacy and pharmacology.

• Knowledge of federal and state laws regulating the practice of pharmacy.

• Knowledge of pharmacoeconomics.

• Knowledge of clinical rationale and medical policies associated with prescription drugs.

• Knowledge of the use and functionality of Microsoft Office Suite software.

• Ability to analyze, interpret, and communicate regulations, policies, and procedures.

• Ability to communicate effectively orally.

• Ability to communicate effectively in writing.

• Ability to establish and maintain effective working relationships.

FULL PERFORMANCE KNOWLEDGES, SKILLS, AND ABILITIES: (NOTE: These are expected of an employee performing the work of this job at the full performance level. These are not used for merit system evaluation or examination purposes and are not position-specific performance standards.)

• Knowledge of agency programs with pharmaceutical and medical device components and the issues affecting those programs.

• Ability to evaluate and provide technical assistance on pharmaceutical and medical device issues.

• Ability to coordinate among various governmental entities to ensure regulatory compliance and avoid duplicative services.

MINIMUM EXPERIENCE AND TRAINING: (NOTE: Based on the Entry Level Knowledges, Skills, and Abilities)

• Two years of experience as a licensed pharmacist dispensing medication and counseling patients on prescription and over the counter medications.

SPECIAL REQUIREMENTS:

• All positions require possession of an active license to practice pharmacy as issued by the Pennsylvania State Board of Pharmacy.