Assoc Pharmacovigilance Solutions Mgr


Accountable for management and service delivery excellence of a range of medium to large sized regional and global projects as assigned by senior staff, covering single or multiple Lifecycle Safety functions. Provide leadership and accountability for customer-facing activities and operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers, aligned by accounts


  • Manage customer interface and communication for assigned projects/programs. 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 Service Delivery Team members in Service Operations (SO).
  • 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.
  • Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defence to service delivery; and throughout the development and commercial life cycle of the product.
  • Manage realization/profitability for assigned projects/programs. Update financial systems, including revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.
  • Ensure financial project performance through oversight of key performance metrics (revenue, direct costs, time-sheet costs, utilization and realization.
  • Develop specialist expertise in aligned specialist areas, as well as applying them across LSM and SO.
  • 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.
  • Actively participate at meetings with internal & external stakeholders. Provide project status updates, defines processes, project/planning strategy.
  • Provide leadership for Lifecycle Safety virtual project teams: keep local/global ILS team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status.
  • Participate in sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as required.
  • Incorporate strategic options when defining project/program scope and processes with customer.
  • Support customer relationship into partnership mode; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal.
  • Work in a customer centric fashion analyzing customer needs and developing innovative, cross-functional strategic solutions within ILS service lines to meet customer needs.
  • Participate in client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans (CAPs).
  • Collaborate with other LSM managers to address and resolve customer needs and issues.
  • Provide historical perspective and input on clients and processes, in collaboration with Service Operations.
  • Work with Lifecycle Safety Service Operations constructively in a matrix framework to achieve project and customer deliverables
  • May assume the responsibilities of EU QPPV or deputy QPPV as outlined in Quintiles Work Instruction: CS_WI_LS0013 Lifecycle Safety-Qualified Persons for Pharmacovigilance (QPPV).


  • In dept knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles Standard Operating Procedures.
  • Working knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
  • Effective team management and leadership skills, conflict management.
  • Strong project management; planning and organisational skills.
  • Effective verbal and written communication skills including ability to network and lead teleconferences.
  • Effective collaborative, organizational and delegation skills.
  • Ability to work 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.
  • Effective judgment, negotiating, decision-making, and problem solving skills.
  • Creative and innovative, initiative and pro-active.
  • Effective business acumen and financial analytical skills, tactical planning, budgeting.
  • Cross trained in a minimum of two Lifecycle Safety service lines.
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers and clients.


Bachelor’s degree or educational equivalent in health science or other directly related field and 5 years’ clinical research experience in a Contract Research Organization or Pharmaceutical company including at least 3 years’ of Lifecycle Safety experience(Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) or equivalent combination of education, training or experience.


Extensive use of keyboard requiring repetitive motion of fingers.

Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

Regular sitting for extended periods of time.

Requires frequent domestic and occasional international travel.

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