Outsourcing Pharmacovigilance Services: Models for Big and Small Pharma

Outsourcing Pharmacovigilance Services: Models for Big and Small Pharma

Manufacturers of all sizes can benefit from outsourcing pharmacovigilance activities. The expertise, systems and flexibility provided by a vendor can complement current activities or even provide an entire team without the need to hire individual staff members. The scale of an outsourcing partnership largely depends on the size and needs of the pharmaceutical or biotech manufacturer.

Large Pharma
Despite robust enterprises, there are many reasons for a large pharmaceutical manufacturer to outsource pharmacovigilance activities.

  • Cost savings
    Outsourcing allows instant access to trained professionals, eliminating the need to hire, train and retain staff. Ultimately, this results in a cost savings. It also allows the internal team to focus on their core competencies.
  • Leverage existing systems and SOPs
    Large manufacturers haves systems and standard operating procedures (SOPs) in place, which a vendor can access. This allows programs to be initiated quickly and to the client’s specifications. The vendor will act as an extension of the Pharma team.
  • Scalability
    Because many large companies have some pharmacovigilance staff and systems in place, a vendor can be leveraged to complete a subset of activities, such as case processing, safety writing or literature screening.

Small Pharma and Biotech
Smaller organizations also have a variety of reasons to partner with an external vendor for pharmacovigilance.

  • Expertise / extension of existing team
    Experts in a wide range of areas (medical, regulatory, technology) can be leveraged without the need to hire new or numerous staff to get the full range of expertise necessary for a top quality safety and Pharmacovigilance handling.
  • Access to existing SOPs and systems
    Developing the right systems and SOPs to support long-term Pharmacovigilance activities is very costly. Small manufacturers look to partner with vendors who have systems and procedures already in place, eliminating the time and expense of starting from scratch. Ideally, these systems are adaptable to the company and product.
  • Flexibility
    The vendor will follow the sponsor's development plans and build a pragmatic and compliant system to meet requirements.

In any model, the outsourcing of Pharmacovigilance activities must be carefully planned to get to success. It’s important to choose a vendor wisely and aim for a true partnership. Any agreement should have realistic and meaningful key performance indicators. Collaboration should happen at every step in order to build strong processes and set clear expectations. Keeping these considerations in mind will lead to a winning situation for all: the manufacturer, the vendor and the patients.

Learn more by viewing my webinar or contact me to discuss your Pharmacovigilance needs.