Senior Manager, Safety and Pharmacovigilance

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Being the heartbeat of Denver means our heart reflects something bigger than ourselves, something that connects us all:

Humanity in action, Triumph in hardship, Transformation in health.

Department

• Managerial Responsibilities
  * Adheres to, complies with and demonstrates support for the mission and values of Denver Health. Supports and adheres to the Denver Health Pillars. Develops and maintains established departmental policies and procedures for quality improvement and pharmacovigilance operations.
  * Works with Management to develop departmental policies and procedures as needed to assure consistent and effective operations that meet contractual and regulatory obligations.
  * Follows all applicable departmental and enterprise policies & procedures.
  * Communicates and trains or coordinates with trainers to appropriately train staff regarding policies & procedures. Must monitor staff's adherence to these policies and take action when they are not followed.
  * Develops and leads staff meetings regarding general operations.
  * Delivers positive customer service and follow up on client complaints.
  * Develops and implements work schedules and assignments to ensure appropriate staffing to meet anticipated volume, required service levels and training needs. Regularly monitors case volume and service levels adjusting staffing and assignments to meet changes. As needed, directs/staffs for coverage during periods of high volume, staff shortages and emergencies.
  * As necessary due to employee absence, redirects work schedule assignments to assure that critical positions are staffed.
  * Dresses professionally, appropriate to the work location.
  * Promotes positive interpersonal (customer) relationships with fellow employees, callers, clients and visitors. Treats these individuals with courtesy, dignity, empathy and respect; consistently displays courteous and respectful verbal and non-verbal communications.
  * Sets clear expectations for staff by developing job specific customer service expectations and behaviors for each position supervised; clearly communicates expectations to each employee and establishes the expectations as job requirements and performance appraisal components; delegates responsibility/authority whenever possible.
  * Identifies training and staff development needs of employees and ensures appropriate training provided.
  * Initiates formal/informal activities with employees to develop departmental cohesion and collegiality.
  * Recognizes positive behavior and contributions to the organization using praise, appreciation and rewards.
  * Actively identifies problems and opportunities for improvement; identifies appropriate solution and involves others in the implementation process.
  (50%)
• Daily Operations
  * Oversees the daily operation of the department by supervising pharmacists, registered nurses and administrative staff.
  * Ensures all legal and professional healthcare requirements are adhered to including contractually required activities.
  * Assures that various required practices are performed and documentation is maintained:
  * Prepares various reports and maintains records or supervises the maintenance of records as required depending upon both regulatory requirements as well as the client needs. Ensures completion and submission of metric and periodic reports as applicable and appropriate.
  * Acts as the primary point of contact and works directly with clients to address current issues, new projects/training, coordinate teleconferences and manage client requirements.
  * Responsible for submitting requests for account creation to both Denver Health and the client and completing other Denver Health orientation activities as required.
  *Assists in Business Development activities under direction of the Director of Pharmacovigilance
  (40%)
• Training and Development of team members
  * Coordinates and plans activities of current and new staff.
  * Works cooperatively with other staff members to enhance the team concept.
  * Works with the Trainer and client to provide and document initial and ongoing training to staff as required.
  * Understands and can train on client processes
  * Addressing ICSRs for consumers and healthcare professionals in a timely, courteous and professional manner.
  * Assures the capture and submission of adverse event reports within the required timeframes.
  * Assures the appropriate completion of follow-up as needed based on situation.
  * Documents information reported and actions taken in a clear, concise and accurate manner within the PV database or MedWatch 3500 form.
  * Performs literature surveillance, signal detection and outbound follow-up with callers or clients if applicable.
  (5%)
• Quality Assurance
  * Works closely with the Quality Team and client to assure that the department meets FDA requirements and client specifications.
  * Takes an active role in audits regarding potential clients, current clients and regulatory agencies.
  (5%)

• Bachelor's Degree Nursing Science Required or
• Doctorate Degree PharmD Required

• 4-6 years Typically of managerial/supervisory experience to include administration and operations. Required and
• 4-6 years A minimum of 5 years experience operating in a regulatory environment Required

• RN-Registered Nurse - DORA - Department of Regulatory Agencies Required or
• PHA-Licensed Pharmacist - DORA - Department of Regulatory Agencies Required

• Knowledge of training and supervisory techniques.
• Ability to instruct, direct, and evaluate employees.
• Will be required to assume responsibility for the staff management and over all operation of the assigned project(s).
• Also communicates with the client(s) to meet goals and improve existing systems and processes.

Shift

Work Type

Salary

Benefits

• Outstanding benefits including up to 27 paid days off per year, immediate retirement plan employer contribution up to 9.5%, and generous medical plans

• Free RTD EcoPass (public transportation)

• On-site employee fitness center and wellness classes

• Childcare discount programs & exclusive perks on large brands, travel, and more

• Tuition reimbursement & assistance

• Education & development opportunities including career pathways and coaching

• Professional clinical advancement program & shared governance

• Public Service Loan Forgiveness (PSLF) eligible employer+ free student loan coaching and assistance navigating the PSLF program

• National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) eligible employer

Our Values

• Respect

• Belonging

• Accountability

• Transparency

All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made.

Denver Health is an integrated, high-quality academic health care system considered a model for the nation that includes a Level I Trauma Center, a 555-bed acute care medical center, Denver's 911 emergency medical response system, 10 family health centers, 19 school-based health centers, Rocky Mountain Poison & Drug Safety, a Public Health Institute, an HMO and The Denver Health Foundation.

As Colorado's primary, and essential, safety-net institution, Denver Health is a mission-driven organization that has provided billions in uncompensated care for the uninsured. Denver Health is viewed as an Anchor Institution for the community, focusing on hiring and purchasing locally as applicable, serving as a pillar for community needs, and caring for more than 185,000 individuals and 67,000 children a year.

Located near downtown Denver, Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.

Denver Health is an equal opportunity employer (EOE). We value the unique ideas, talents and contributions reflective of the needs of our community.

Applicants will be considered until the position is filled.