Associate Pharmacovigilance Solutions Director
dublin, Ireland
2d ago
source : Experteer

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 OVERVIEWJob Profile SummaryProvide strategic leadership at customer (or strategic) account level for large post-marketing, clinical trial or combination programs or customer accounts, as assigned by senior management team.

Act as a senior level point of contact throughout project duration for local and globally scoped deliverables with single / multiple Lifecycle Safety functions.

Collaborate with global management team and integrated partners to develop and implement strategic initiatives / solutions and ensure global consistency.

  • Manages the delivery of lifecycle safety scope from pre-award, project initiation / transition to closeout.Ensures quality deliverables are presented on time and within budget;
  • coordinates work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies;
  • identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project customer.

    ResponsibilitiesEssential FunctionsManage customer interface and communication for large programs or standalone projects.

  • Represent Lifecycle Safety on projects / programs; 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 / programs.

    Tactical, day-to-day customer-facing leadership at project / program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management.

    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 structure for customer service interface from scoping stage, through proposal generation, bid defense to transition of work and service delivery;
  • and throughout the development and commercial life cycle of the product.Attend Joint Operating Committee Meetings and / or Governance meetings to provide portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner with customers at a Senior Management Level.

    Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.

    Manage finances for assigned projects / programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.

    Ensure financial project performance through oversight of key performance metrics (i.e. revenue, direct costs, time-sheet costs, contribution margin).

    Develop specialized expertise across the Pharmacovigilance spectrum (e.g. Global Regulatory, Regulatory reporting requirements), and apply this expertise within assigned projects, and cascade knowledge to PV Solutions team as appropriate.

    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.

    Manage 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.

    Lead meetings with internal and external stakeholders. Provide project status updates, defines processes, project / planning strategy.

  • Provide leadership for Lifecycle Safety virtual project teams : keep local / global Lifecycle Safety team current on project developments;
  • lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams, to ensure projects / programs are delivered in accordance with customer expectations.

    Facilitate sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as needed.

  • Incorporate strategic options when definingproject / program scope and processes with customer.Develop customer relationships into partnerships;
  • manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal.

    Facilitate discussions on new business opportunities with existing customers.Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross- functional strategic solutions within Lifecycle Safety service lines to meet customer needs.

    Actively contribute during client and internal audits and inspections for assigned project. Liaise with Quality Assurance staff and management in the compilation of corrective action plans.

    Identify and drive departmental initiatives aimed at enhancing customer service, efficiency, quality, or employee engagement.

    Represent LS Leadership at select external and internal meetings.Takes on a higher level of leadership within the department to mentor and support junior leads.

    Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency.Perform other duties as assigned.

    MINIMUM REQUIRED EDUCATION AND EXPERIENCETo performthis job successfully, an individual must be able to performeachessential duty satisfactorily.

    Therequirementslisted below are representative of theknowledge,skill, and / or abilityrequired.Reasonableaccommodations may be made to enableindividualswithdisabilities to performtheessentialfunctions.

    Experience Typically requires 6 - 7 years of prior relevant experience.Knowledge Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.

    Typically viewed as having a specialty within discipline.Education Bachelor's Degree in Health science or other directly relatedfieldProject Management Professional (PMP) Certification would be idealAdditional Work Experience6 to 7 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 6 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.

  • and 3 years' project management experienceOrEquivalent combination of education, training or experienceSkills and Abilities In-depth 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.

    In-depth knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.

    Strong team management and leadership skills, conflict management.Strong project management; planning and organizational skills.

    Effective verbal and written communication skills including ability to network and lead teleconferences.Effective collaborative, organizational and delegation skills.

    Ability to establish and maintain effective working relationships with coworkers, managers and customers.Ability to deliver on multiple projects and manage competing priorities.

    Ability to manage ambiguity.Effective business focus, marketing, sales skills.Proven strong presentation; report writing skills and customer focus skills.

    Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared accountabilities.

    Independent judgment, negotiating, decision-making, and problem-solving skills.Effective business acumen and financial analytical skills, tactical planning, budgeting.

    Customer focused with effective relationship building skills.Effective motivating, influencing and conflict resolution skills.

    Join UsMaking 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.Full time

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