Mid - Sized Company

Mid-Sized Companies have several products, likely across at least two therapy areas, and are frequently marketing their products globally both directly and via partnerships.  The complexity of these organizations requires increased attention to the safety process.  As well, companies at this stage frequently undergo management changes and PV departments are often asked to revalidate their sourcing strategy, either to consider repatriating outsourced functions or outsource internal functions.

These companies have needs that include

• Attention to scalability – costs and risks rise quickly as volume of information increases.  Efficiency and scalability become important for two reasons
  • Cost effectiveness
  • Compliance – whereas small companies can scrutinize each piece of data, standardization becomes higher priority as volume increases
• Quality – a quality management system (QMS) is key at this stage.  The QMS must include
  • Training
  • Documentation change control and maintenance
  • Metrics
  • Root cause analysis, corrective/preventive action process for compliance breaches
• Operational - repeated activities such as preparation of aggregate reports need to be standardized and operationalized as frequency increases
• Knowledge based - for example, regulatory reporting requirements increase in complexity with broader geographic footprint
• Technical issues – database needs to be more robust with increased capabilities for searching as well as initial stages of quantitative signal detection

SSI Strategy can assist companies at this stage by performing build or buy analyses, redesigning processes and procedures to ensure compliance and efficiency, building the QMS (including written procedures [SOPs], metrics and dashboards, quality investigation and corrective/preventive action process) to suit the company needs.  SSI can also provide direct operational support on a large scale or as supplemental to internal resources.

Managing a Pharmacovigilance organization within a large pharmaceutical corporation is as complex as managing any other large division.  PV departments face the same challenges all departments face, including:

• Financial
• Human resource
• Global organizational footprint
• Complex regulatory environment

 Challenges that are somewhat unique to PV include difficulty demonstrating value to the overall company and inability to forecast demand for information handling resources, compliance resources and aggregate analysis resources.  These challenges are in direct conflict in that the first requires the organization to run itself lean, and the second requires maintenance of overcapacity to meet peaks in demand where stakeholders are unable to inflexible in specifications (reporting timelines, etc.).

Some of the challenges faced by large pharmaceutical companies include:

• Complex product portfolios across multiple therapy areas
• Geographically diverse PV activities
  • Requirement for translation from multiple languages
  • Timezones
  • Cultures
  • Different reporting requirements
• Complex internal structures and stakeholder groups
  • Often rely heavily on functions outside core PV that may not be aware of PV system needs
• Frequently multiple types and structures of partnerships
• A rich compliance history with resultant commitments to track and meet
• Frequently insufficient tools for all the tracking that is required
• Large and complex safety databases require significant technical support and maintenance

SSI Strategy is well aware of these realities and we have a host of tools at our disposal to assist with meeting the challenges faced by large PV organizations.  Our experience in PV as well as strategy consulting allows us to provide your department with support to the same level of quality as other functions enjoy while maintaining an understanding of the context in which PV must work.