Director of Quality Assurance and Program Drug Safety Reporting

The Director of Quality Assurance and Program Drug Safety Reporting is responsible for the direction and leadership of operational, financial, programmatic and employee related activities for Quality Assurance and Program Drug Safety Reporting. This includes establishing, meeting and continuously monitoring the goals and objectives while maintaining alignment with the strategic goals and objectives for AssistRx and meeting client contractual obligations. While the range of duties and responsibilities is broad and varied, the position's major responsibility is directing the day-to-day operations, budget/financial management, management of associate resources and client alignment. The Director works closely with a variety of stakeholders, directing the activities of Quality Assurance and individual client program drug safety reporting across the enterprise. The Director of Quality - Patient Safety serves as the programmatic and operational leader for Quality - Patient Safety and is responsible to the Vice President, Patient Solutions.

Responsible for directing, planning and coordination of programs and their activities

• Monitor implementation of program features, services, policies and practices
• Support program growth and development as necessary
• Direct the department leadership team to manage staff work assignments, workloads and work schedules
• Administer or oversee the new QA team member onboarding and training
• Schedule and organize program-related meetings and events
• Oversee the use of technology for program operations, such as Verint Quality Management (evaluation forms/templates), Verint Speech Analytics and Verint reporting
• Create and maintain department SOP's, Job Aides, FAQ's and Work Instructions.
• Strong organizational and multi-tasking skills
• Excellent analytical and problem-solving abilities
• Team-management and leadership skills
• Documentation management and ability to use project/program management tools
• Time management skills with the ability to meet deadlines
• Excellent communication and interpersonal skills to include the ability to negotiate and resolve conflicts and build teams.
• Demonstrated creativity and flexibility.
• Ability to operate in high-pressure situations.
• Excellent organizational skills.
• Demonstrate innovative approach to problem resolution.
• Ability to work collaboratively across AssistRx departments and disciplines.
• Broad knowledge of pharmacovigilance and drug safety practices and principles
• Effective analytical ability in order to develop and analyze options, recommend solutions to and solve complex problems and issues.
• Demonstrated effective managerial and administrative leadership of operations Knowledge of principles and techniques used in negotiation as applied to service contracts.
• Effective organizational, planning and project management abilities.
• Ability to function independently and deal with multiple, simultaneous projects
• Ability to implement change in a positive, sensitive and forward- thinking manner
• Participate in RFP and Business Development Initiatives as asked
  
  
  

Requirements

• Bachelor's degree in a relevant subject area such as Quality Assurance, Quality Management, Pharmacovigilance Drug Safety reporting
• At least 5+ years professional experience in management of Quality Assurance and Drug Safety team members
• Experience coordinating resources and managing project timelines
• Strong project management and organization skills
• Influencing and relationship building; builds a network of experts and resources to support programs
• Creative problem solver; naturally curious and can quickly research issues
• Can successfully deal with a fast-paced environment with competing priorities across multiple stakeholders
• Effective communication skills; writing, editing and verbal communication skills
• Ability to communicate effectively with technical and non-technical team members
• Excellent presentation skills
  
  
  

COMPETENCIES:

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed
• Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information
  
  
  

Benefits

• Medical, dental, vision, life, & short-term disability insurance
• Teledoc services for those enrolled in medical insurance
• Supportive, progressive, fast-paced environment
• Competitive pay structure
• Matching 401(k) with immediate vesting
• Legal insurance
  
  

AssistRx, Inc. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors, or any other protected categories protected by federal, state, or local laws.

All offers of employment with AssistRx are conditional based on the successful completion of a pre-employment background check.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Sponsorship and/or work authorization is not available for this position.

AssistRx does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of AssistRx and no fee will be paid in the event of a hire.