Manage performance and development of staff and direct reports to ensure achievement of organizational and departmental goals and a productive work environment; manage and communicate performance and compensation related information per organization guidelines.

More Uses of the Pharmacovigilance Toolkit:

  • Standardize: conduct quality management oversight of project deliverables to ensure that content is in accordance to the clients business objectives and expectation.
  • Support the development of assessment tools, training programs, policies and interpretation of requirements.
  • Align activities and account plans to marketing programs and management direction in line with the Solution Selling model.
  • Serve as a key member of your team by developing key performance indicators that follow your clients objectives and effectively supporting client deliverables and timelines.
  • Confirm you maximize; lead strategy and ensure development, implementation, and adoption of robust investigations and corrective/preventative action plans, and utilization of quality measures to drive continuous improvement.
  • Manage: risk identification and assessment through data review and quality control processes either remote or on site.
  • Be accountable for improving communication pathways and information sharing by utilizing applications as SharePoint, Forms, Flow, etc.
  • Perform periodic review and summary of pertinent safety related literature and analysis of pre determined core signal data.
  • Maintain high level of expertise with the evolving portfolio of products, services, pricing, competition, market and industry trends.
  • Deliver relevant marketing messages, product information and programs consistent with management direction in line with Solution Selling model.
  • Inform heads of quality management, heads of the assigned business line and quality assurance of quality issues according to SOPs.
  • Contribute to the design, tracking and follow up of risk management plans for the products assigned and assure sound implementation.
  • Confirm your venture participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
  • Oversee development of training modules and provide training in Pharmacovigilance across your organization.
  • Secure that your organization applies and promotes Lean manufacturing techniques to continuously improve cycle times and process flows.
  • Confirm your strategy ensures all assigned sites and project specific site team members are trained and compliant with applicable requirements.
  • Secure that your strategy develops and implements risk management processes for identifying and prioritizing areas of compliance risk and allocating appropriate resources to handle that risk.
  • Ensure your organization provides Pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.
  • Collaborate with center of excellence for signal detection and data mining and safety epidemiology group.
  • Provide strategic and proactive safety input into development plans Support due diligence activities and Pharmacovigilance agreements.
  • Support interactions with, business partners (license partners) and vendors for all case intake and processing activities.
  • Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
  • Be certain that your organization serves as primary interface between organization, sponsors, vendors, and other departments in the area of safety.
  • Oversee and review reports on safety issues and implications for the Core Safety Information and Core Risk Minimization Activities.
  • Be accountable for operating at pace and Agile decision making using evidence and applying judgement to balance pace, rigour and risk.
  • Ensure you enhance; lead client team interactions on behalf of project delivery teams to mitigate risks and escalated issues.
  • Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management and corrective/preventive actions.
  • Develop mutually beneficial and productive long term partnerships with your customers based on high quality account plans.
  • Ensure you exceed; lead and oversee and direct all aspects of Pharmacovigilance and risk management activities for development products and potential marketed products.
  • Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery.

 

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