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Associate Safety Aggregate Report Manager

Quintiles

Dublin, Ireland

PURPOSE

Apply knowledge and expertise in the area of safety aggregate and benefit risk management documents. Actively contribute to One Q Safety global process initiatives and work in close collaboration with the safety customer delivery management team and Safety Infrastructure regarding project/client initiatives. Ensure team is following standard best-in-class practices established by SARA infrastructure.

RESPONSIBILITIES

  • Analyze data, author and review complex aggregate reports of safety data;
  • Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Aggregate Reporting and Analytics (SARA) and Benefit Risk Management (BRM);
  • Serve as principal owner of SARA and BRM deliverables; responsible for completion of the document in compliance with all applicable regulatory requirements and customer service level agreements;
  • Prepare each version of the deliverable and maintain version control of the document. Request source documents from other Quintiles departments or customers. May also request example documents, style guide and other documents (e.g., signal analyses, regulatory correspondence) as deemed necessary;
  • Attend internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget. May also serve as the Program Lead (where there are multiple SARA projects within the same programs) or the customer representative/relationship manager (if identified). Address all review comments by both internal and external stakeholders;
  • Chair planning meetings, data interpretation meetings, online documents review meetings, as required;
  • Interface with other functional groups, such as Regulatory Affairs, Clinical/Medical Affairs functions, Quality, Information Technology, or other business units as needed;
  • Manage resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions;
  • Lead or participate in project teams and committees as assigned. Initiate new projects to improve processes;
  • Provide mentorship and training to less experienced resources;
  • Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for less experienced team members;
  • Ensure compliance to Quintiles high quality standards and works with LSM, Medical and BRM constructively in a matrix framework to achieve project and customer deliverables;
  • Participate in training across One Q safety process service offerings; participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies;
  • Lead team and contribute to achieving departmental goals and metrics e.g. productivity utilization and realization metrics;
  • Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable;
  • Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies;
  • Participate in the review of existing standard operating procedures (SOPs);
  • Proactively identify issues and proposed solutions.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • In-depth knowledge of Lifecycle Safety processes audit practices, governing safety legislation/regulation; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills;
  • In-depth knowledge and understanding of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles SOPs;
  • Strong organizational skills and attention to quality compliance;
  • Mentoring and coaching skills;
  • Strong project management and leadership skills;
  • Strong presentation and customer focused skills;
  • Effective judgment, decision-making and problem solving skills;
  • Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives;
  • Ability to multitask and prioritize;
  • Demonstrate strong cooperative relationship with team and LSM;
  • Excellent written and verbal communication skills, effective report writing skills;
  • Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities;
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

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

PHYSICAL REQUIREMENTS

  • 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;
  • May require occasional travel.

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