Adjunct Instructor, Medical Product Safety/Pharmacovigilance

Do Great Things! Durham Technical Community College is hiring an adjunct

instructor in the Clinical Trials Research Associate and Medical Product Safety Program.   The instructor (part-time) of Medical Product Safety/Pharmacovigilance is primarily responsible for the planning, delivery, and evaluation of classroom instruction, and providing related services and support activities required for optimal student learning and effective educational programming. As a member of the Health and Wellness faculty, the instructor is also accountable for assisting and supporting their assigned program director, field coordinator, and/or department dean, as needed, in meeting the instructional and curricular requirements of their program, department, and division.

More specifically, and consistent with the employee's current contract of appointment, the instructor is responsible for the following duties and responsibilities:

• Teach all courses as assigned, for the full duration of scheduled instruction;

• Be fully prepared with course syllabus and instructional plans for each class session in accordance with the stated objectives of the course;

• Enforce academic policies and procedures of the College and the department at all times, and complying with all other institutional rules and regulations pertinent to classroom instruction and general employment;

• Complete required institutional and instructor trainings as assigned

• Be available during posted out-of-class hours to students requiring additional assistance;

• Contribute to the development, implementation and evaluation of competency-based education and utilize available educational resources for the evaluation, improvement of instruction and the development of teaching materials; 

• Take advantage of in-service training and other opportunities for continued professional development, including attendance at off-campus activities, as feasible, and generally staying abreast of developments in the field of instruction; 

• As appropriate or as requested participate in program, departmental, divisional, and instructional meetings and other announced activities;  

• Assume other necessary responsibilities and perform additional tasks as assigned by the program director and/or department dean in meeting the needs of the program, department, division, and the College.

Minimum Qualifications:

• Education:  A baccalaureate degree or higher in pharmacy or pharmaceutical sciences is also acceptable, but with additional years of experience (see #2 below) is required. A PharmD, PhD in pharmaceutical sciences or related field, MD, or master's degree in a medical field (i.e., nursing, pharmacy) is preferred.

• Professional Experience:

•  Instructors with a bachelor's degree must have at least eight years of professional experience in these areas.

•  Instructors at a master's degree level or higher must have at least three years of professional experience in pharmacovigilance and/or drug safety working in the pharmaceutical industry, the medical device industry, and/or the clinical research industry.

• Prior teaching experience is preferred but not required.

Work Experience:

• Instructors with a bachelor's degree must have at least eight years of professional experience in these areas.

• Instructors at a master's degree level or higher must have at least three years of professional experience in pharmacovigilance and/or drug safety working in the pharmaceutical industry, the medical device industry, and/or the clinical research industry.

Knowledge, Skills, and Abilities:

• Evidence of strong interpersonal skills, organizational skills, and effective oral and written communication/public relation skills;

• Excellent problem solving and critical thinking skills;

• Ability to manage multiple tasks and meet deadlines;

• Ability to think creatively and put ideas into action;

• Ability to make presentations to large audiences;

• Excellent computer skills as evidenced by experience and competence with Microsoft Office products and a learning management system such as Canvas.

• Personal integrity, honesty, and the ability to maintain confidentiality; and

• Understanding of the mission, goals, and objectives of a community college.

Drug Safety/PV Core Competencies:

• Describe lessons learned from prominent events in the history of drug safety and application to the current field.

• Advanced knowledge of national (US) and international drug safety regulations (pre- and post-marketing), Good Pharmacovigilance Practices, medical terminology and guidance documents.

• Interprets and applies national and international drug safety regulations, terminology and guidance documents to daily pharmacovigilance workflow including individual case safety reports as well as aggregate safety reports.

• Advanced knowledge of the cycle of drug development.

• Knowledge and application of safety standards to writing of individual case safety report narratives, safety sections of study protocols, clinical study reports, annual and bi-annual safety reports, investigator brochures, and integrated summaries of safety.

• Advanced knowledge of coding, workflow and report producing procedures within validated safety databases.

• Advanced knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug Global).

• Advanced knowledge and application of adverse event expectedness/labeling assessments and labeling documentation. Participation in writing of labeling documents, including Investigator Brochures, package inserts, summary of product characteristics.

• Advanced knowledge of components of causality determination.

• Advanced understanding and application of follow-up/due diligence in case processing.

• Advanced knowledge of risk/benefit analysis and practical application. Creation and maintenance of risk evaluation mitigation strategies (REMS) and risk management plans (RMPs).

• Advanced knowledge and application of signal detection functions, including regular review of adverse event listings and data mining.

Physical Demands:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. The physical and mental demands described as follows are representative of those that must be met by an employee in performing the essential functions of this job:

• Ability to sit and/or stand for long periods of time;

• Ability to lift, at times, 10 lbs.; and

• Good eye/hand dexterity.

Normal Working Hours:

As defined in the employment contract. Specific work hours are to be determined by the scheduled class hours and by consultation with the supervisor. Hours are not guaranteed but are based on student enrollment and faculty needs.