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Outsourcing PV: Core Competencies

Posted on December 7th, 2016 by in Pharmacovigilance


In a previous posting, we reviewed the drivers for the decision to outsource some or all pharmacovigilance (PV) activities. What activity to outsource is the next critical step. We need to identify what should be considered as core competencies (CC) that we want to keep in house and the activities that should be outsourced to a vendor. In the PV world, core competencies can be:

  • specific expertise areas that cannot be easily delegated, such as deep knowledge of the product(s) safety profile, pre-clinical and clinical data;
  • critical activities that have a preeminent impact on business decisions, such as benefit-risk assessment, safety elements of the registration dossier, identification of the elements of a Risk Management Plan or Risk Evaluation and Mitigation Strategies.

Each company should review key PV activities one-by-one and identify if each one is a specific asset that can or cannot be transferred out:

  • Can such activity be outsourced without excessive knowledge transfer and intense oversight?
  • Can the experience and knowledge related to the activity be found in the market without too much hassle?
  • Does keeping the activity in-house represent a significant added value to the business and an efficient use of the department resources?


Let us review the key segments of PV activities to suggest what can be easily or not transferred out with or without significant benefits.

  • Pharmacovigilance Database. During the pre-clinical or marketing phases, using a market standard PV database is an absolute need to satisfy regulatory requirements and signal detection activities, in addition to the clinical trial database. Acquiring, hosting and maintaining such a PV database can be costly. There are interesting database options on the market allowing to avoid to own and manage the system. It is also possible to disconnect the database hosting (IT part) from the PV service vendor (such as case processing). The recommendation for small organizations or mid-size organizations is to outsource the PV database.
  • Call center, case intake, case entry, follow-up activities: there are many vendors on the market with significant medical expertise and robust systems to take care of these activities 24/7/365, with the ability to ramp up activities when needed, including crisis situations or new product launch. Since this is a key point for collecting AE information, the reconciliation, timelines for exchanges and activities oversight must be perfectly organized and executed. Follow-up activities (documenting AE reports) must be proportionate to the severity/seriousness of the event and executed by trained health care professionals. A constant reconciliation process with PV on medical information, and product quality complaints is an absolute need. There are many trustworthy vendors on the market, with excellent track records. For small organizations, the recommendation is to outsource with a trusted partner, with adequate oversight and controls. For mid-size companies, both options are viable. There are many advantages to keeping these activities in-house, with a higher cost. The critical decision point is your ability to create a compelling business case for keeping this in-house. For large organizations, the corporate motto is outsourcing, though hybrid models exist.
  • Triaging, causality assessment, medical narrative and coding: because of the impact of compliance to reporting to Health Authorities and the need to have a consistent coding and narrative writing for signal detection purposes, a very close monitoring or direct ownership is preferred. The best option is to let the PV vendor prepare proposals for these activities, with a quick review for approval/correction at the company’s site. The recommendation is to outsource with close supervision and review/approval loop.
  • Literature review can be easily outsourced with significant benefits, focusing not only on individual cases but also with the identification of new information (pre-clinical, epidemiology, class effect, etc.) potentially impact the benefit-risk profile of the company’s drugs.
  • Signal detection and benefit-risk assessment: this is the most delicate responsibility to delegate. Because of the complexity and sensitivity of performing signal detection and benefit-risk assessment activities, and the unique nature of each product, outsourcing might not be the preferred option. A strategic partnership though, with a well-trusted expert company, could be considered if the company is not staffed for these activities. It is ultimately the responsibility of the sponsor/MAH to ensure that all signals are detected and the risks are minimized for the patients. Extreme care should be exercised when outsourcing.
  • Aggregate reporting: the generation of data, listings and draft reports can be delegated to many existing qualified vendors, as long as the company keeps a good oversight and quality control of the report generation, overall recommendations, and conclusions. Many companies have difficulties to stay with one vendor because of the challenges of managing successfully this partnership, and hope that the next vendor will work better than the previous one. Companies should be able to recognize if a poor output results from a true lack of competency at the vendor site, or from the inability from the company (and the vendor) to establish a true partnership with efficient, trusted and open collaboration on the project. This point indeed applies to all types of delegation to vendors, not only aggregate reports. The recommendation is therefore to outsource, but engage in long term partnership with your vendor(s).
  • Safety Data Exchange Agreements: preparing and monitoring Safety Data Exchange Agreements is rarely outsourced for good reasons. It is often a highly customized and specialized activity with a lot at stake. Companies usually overestimate their ability to correctly prepare these key documents. This is where bringing external expertise can be invaluable and help in building a robust, compliant and efficient SDEA model, with minimized risks for conflict ahead. This should be considered as a true core competency, and external help should be needed only if there is a knowledge gap on how to prepare such agreements.
  • Reporting to partners, Health Authorities: most companies prefer to handle this in-house, probably because they should be the primary contact entity for any discussion with health authorities, in and out. However, there is indeed little added value for Regulatory (which usually handles the reporting) to complete this last step in a life of a safety report. This could be outsourced to a trusted partner, and only one with an outstanding compliance record and proactive issue remediation mindset.
  • PV Quality Assurance: the level of PV processes, standards and regulation knowledge needed for adequate auditing of PV organizations and developing an inspection readiness program almost always requires bringing in an external consultant to get it done correctly for small companies. Preparing the organization to use and collect adequate metrics, as well as bring an external point of view on the quality strategy and planning required by regulations is another reason to call for outside help. Mid-size and larger organization have the know-how internally and rarely outsource this.
  • REMS and RMP should remain a responsibility of the company, though the management and execution will certainly benefit in terms of performance and costs if outsourced. Ad-hoc expertise adds a lot of value when preparing such documents.
  • Pharmacoepidemiology: although pharmacoepidemiology is an essential contributor to benefit-risk assessment, protocol design, and signal detection activities, small companies rarely have the opportunity to attract and retain a talented expert. Acquiring this expertise from outside is the only choice possible.
  • Post-Authorization Safety Studies: if the design and negotiation with health authorities should always be kept in-house, the execution will always require external resources, with adequate supervision.
  • Review safety sections of protocol, Investigator Brochure: depending on the level and knowledge of internal safety experts, companies may choose to bring in external resources to help on these critical activities if there is not true internal PV expertise. Likewise, the preparation of a Safety Monitoring Plan for clinical trials requires a specific pharmacovigilance expertise that will benefit from an ad-hoc contribution from outside.

Overall, depending on the size of the organization, its strategic development, available resources and growth perspective, many options are offered for outsourcing and off-shoring pharmacovigilance activities. Identifying the company core competencies will help delineate what can be outsourced. The next challenges will be to identify the right partner(s) to whom to outsource, and then establish a trustful, productive and lasting relationship.

JP Clement

Missing adverse events can lead to serious consequences. When a top pharma firm received a regulatory warning letter, they turned to Elsevier.  Read our case study:

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All opinions shared in this post are the author’s own.

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