Snr Safety Project Lead (R1092500) in Durham, NC at IQVIA™

Date Posted: 9/20/2019

Job Snapshot

  • Employee Type:
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.


Job Profile Summary    Responsible for management and service delivery excellence for assigned projects, covering single or multiple Lifecycle Safety functions (clinical trial and / or post-market). Provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers, aligned by accounts. Collaborate with global management team and integrated partners to develop and implement strategic initiatives/solutions to expand business, partnership, strengthen overall relationship and ensure global consistency.

Essential Functions

•    Manage customer interface and communication for assigned projects. Represent Lifecycle Safety on projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.

•    Manage customer deliverables for assigned projects and bring continuity to project design and delivery through customer delivery. Tactical, day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), defining project/scope management, quality management and project financial management.
    May act as an account owner over a program or customer portfolio and therefore report program/portfolio level metrics and provide oversight of projects they do not directly lead.  
    Performs role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities. Formulates operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfil required customization of text and data. Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery.
    Represents as Safety SME. Provide leadership and accountability for customer-facing collateral and operational support to deliver key customer messages, working cross-functionally and across the opportunity lifecycle, integrating lifecycle safety core message delivery into customer facing material, presentations and meetings. Collaborate with senior leadership to implement strategic initiatives and ensure global consistency.

•    Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defence to transition of work and service delivery; throughout the development and commercial lifecycle of the product.
•    Manage finances for assigned projects.  Responsible for updating financial systems. Work closely with manager on revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.
•    Develop specialist expertise and may act as a Subject Matter Expert (SME) on departmental or global initiatives.
•    •    Support start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.
•    Attend meetings with internal (IQVIA cross functional project team members) and external (Customers and/or oversight group members) stakeholders. Provides project status updates, defines processes, project planning/strategy.

•    Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication.
•    Participate in sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as required.
•    Contributes during client and internal audits and inspections for assigned projects.  Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.
•    Work closely with Lifecycle Safety management to address problem areas and customer needs.

Essential Functions
•    Perform other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typically requires 2 - 3 years of prior relevant experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.


Education Level    
Education Details    
Bachelor's Degree    Health science or other directly related field    X        

Additional Work Experience

Experience Details    
2-3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience    X        Or
Equivalent combination of education, training or experience    X        

Skills and Abilities

    Knowledge of applicable global, regional and local clinical research regulatory requirement; i.e.
Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures.        
    Willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.        
    Strong prioritization (critical timelines), planning and organizational skills.        
    Effective verbal and written communication skills including ability to work and lead teleconferences.        
    Effective collaborative, organizational and delegation skills.        
    Independently work on multiple projects and manage competing priorities.        
    Ability to manage ambiguity.        
    Strong presentation (independently present at internal/external meetings) skills; report writing skills and customer focus skills.        
    Accountability, ownership and transparency.        
    Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.        
    Possesses knowledge of business acumen and financial analytical skills, tactical planning, and budgeting.        

Skills and Abilities

    Creative and innovative, initiative and pro-active.        
    Effective motivating, influencing and conflict resolution skills.        
    Ability to establish and maintain effective working relationships with coworkers, managers and customers.        
Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Standard ADA Selection    Office Environment

Physical Demands

Physical Demand    
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.                
Use hands and fingers to handle and manipulate objects and/or operate equipment.                

Travel Requirements

Brief Description
    Requires frequent domestic and occasional international travel

Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.
Problem Solving     
Responsible for making adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.
Problems faced are general and may require understanding of broader set of issues but are not complex.

A. IMPACT Evaluation Factor    

A1 Organization Entity    
•    RBU Latin America    
•    RBU - APAC, Japan; GBU- RWAS; IQVIA universal (jobs below grade 180)    
•    RBU - US & Canada, CESE, NEMEA    
•    GBU - ITS, RDS    
•    IQVIA Corporate    

A2 Impact - Nature and Scope of Influence on its area of responsibility/operation
    0.5 pts permitted
1. Delivery - Delivery according to specific standards and guidelines.    
2. Operational - Work achieves operational targets or service standards.    

A2 Impact - Nature and Scope of Influence on its area of responsibility/operation
    0.5 pts permitted
3. Tactical - Specify new products, processes, standards based on organizational strategy or set short- to mid- term operational plans    
4. Strategic - Establish and implement business strategies with a longer term focus (typically 3-5 years) based on the organization's vision    
5. Visionary - Lead an organization to develop, implement and achieve its mission, vision and values    

A3 Contribution to Organization Results
    0.5 pts permitted
1. Limited - Hard to identify/discern contribution to achievement of results    
2. Some - Easily discernible or measurable contribution that usually leads indirectly to achievement of results    
3. Direct - Directly and clearly influences the course of action that determines the achievement of results    
4. Significant - Quite marketed contribution with authority of a frontline or primary nature    
5. Major - Predominant authority in determining the achievement of key results    

Summary Statement from Impact & Contribution Ratings:
B. COMMUNICATION Evaluation Factor

B1 Communication - Responsibility for communications within & outside the organization
    0.5 pts permitted
1. Convey - Communicate information by statement, suggestion, gesture, or appearance    
2. Adapt and Exchange - Reach agreement through flexibility and compromise    
3. Influence - Effect Change without direct exercise of command where persuasion is required    
4. Negotiate - Come to agreement by managing communications through discussions and compromise. Issues are short-term operational, medium-term tactical or limited strategic nature    
5. Negotiate Long Term - Manage communications of great importance having long-term, strategic implications for the whole organization    

B2 Frame - Nature of Communication
    0.5 pts permitted
1. Internal Shared Interests - Common desire to reach a solution within a corporation    
2. External Shared Interests - Common desire to reach a solution outside a corporation    
3. Internal Divergent Interests - Conflicting objectives that inhibit reaching a solution within a corporation    
4. External Divergent Interests - Conflicting objectives that inhibit reaching a solution outside a corporation    
Summary Statement from Communication Ratings
C. INNOVATION Evaluation Factor
C1 Innovation - Identify, develop, and make improvements to new ideas, techniques, procedures, services, or products
    0.5 pts permitted
1. Follow - Compare with a source, original, or authority; no changes are expected    
2. Check - Make minor changes    
3. Modify - Adapt or enhance quality or value in existing methods; make better as part of day-to-day activities    
4. Improve - Change significantly by enhancing entire existing processes, systems or products    
5. Create / Conceptualize - Develop truly new concepts or methods that break new ground    
6. Scientific / Technical Breakthrough - Form and bring into existence major new or revolutionary advances in knowledge or technique    

C2 Complexity
    0.5 pts permitted
1. Defined - Problems and issues to be addressed generally fall within a single job area or discipline; scope of problems is well defined    
2. Difficult - Problems and issues may be only vaguely defined and require understanding and consideration of other disciplines and job areas    
3. Complex - Problems and issues require broad-based solutions requiring consideration of 2 or 3 dimensions - Operational, Financial, and Human    
4. Multi-dimensional - Problems and issues are truly multi-dimensional requiring end-to-end solutions with direct impact on all 3 dimensions - Operational, Financial, and Human    
Summary Statement from Innovation Ratings
D. KNOWLEDGE Evaluation Factor

D1 Minimum level of knowledge required to fulfill one's responsibilities
    0.5 pts permitted
1. Limited Job Knowledge - Fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries    
2. Basic Job Knowledge - Specialized knowledge of specific commercial, technical, trades, or office operations areas    
3. Broad Job Knowledge - Broader knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices    
4. Expertise - Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents    
5. Professional Standard - Mastery of a specific professional discipline combining deep knowledge of theory and organizational practice or expertise across several different disciplines within a function or several different job areas across functions.    
6. Organizational Generalist / Functional Specialist - Broad management experience across several functional areas or businesses, or concentrated knowledge of a particular discipline; considered the organization's expert within a particular discipline    
7. Broad Practical Experience / Functional Preeminence - Broad and substantive management experiences across several line and support functions or businesses, or recognized outside the organization as having paramount capability in a broader discipline/area of study    
8. Broad and Deep Practical Experience - Very significant management experience in several businesses and most line and support functions combined with deep experience in 1 or more of the organization's most important line functions    

D2 Team - Nature of role
    0.5 pts permitted
1. Team Member - Individual contributor, no direct responsibility for leading others    
2. Team Leader - Coaches team members (at least 3) in skills; leads, schedules, and allocates work    
3. Team Manager - Directs more than one team; determines team structure and roles of members    

D3 Breadth - Application of Knowledge
    0.5 ptts permitted
1. Domestic - Locations within a country or neighboring countries with similar culture    
2. Regional - Continental region (e.g. Asia Europe, NA, LA, ME)    
3. Global - All regions of the world    

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at to arrange for such an accommodation.

Job ID: R1092500