What does oversight and delegation mean for the Qualified
Person Responsible for Pharmacovigilance?
Received: December 11, 2016; Accepted: December 16, 2016;; Published:December 26, 2016
The EU/EEA Qualified Person Responsible for Pharmacovigilance
(QPPV) is personally accountable for the pharmacovigilance quality
system of a Marketing Authorization Holder (MAH) in the European
Union/European Economic Area (EU/EEA). This has resulted in a
long list of tasks, implementation of which requires oversight and
delegation. Regardless of how these responsibilities appear in the
legislation, what they mean in reality has neither been defined nor
have they been agreed within the pharmaceutical sector. Based
on our own experience and good business practice, we present a
personal view on how a QPPV should implement oversight and
approach delegation, which can be applied in practice. Training to
fulfill these responsibilities is required as part of the toolkit for the
QPPV, and the management of the MAH is obliged by the legislation
to provide all necessary support to enable the QPPV to discharge his/
Qualified person for pharmacovigilance; Deputy;
Setting the scene
The EU/EEA qualified person responsible for pharmacovigilance
is the most important defined natural person in the EU
pharmaceutical legislation. The extensive role and responsibilities
are described in GVP Module I Section I.C.1.3 . However,
in spite of the exhaustive GVP guidance very little has been written
about, and there is no published consensus on, how this role
should be effectively implemented [2,3]. Indeed, with no agreed
competency framework, it is debatable exactly what it means to
be “qualified”. Thus, based on our own experience of providing
multiple QPPV services in big and small companies over the last
15 years, we would like to share our opinions about how some
aspects of this role might be implemented optimally to maximize
the benefit to both Marketing Authorization Holder (MAH) and
patients as well as to the interrelationships that must be established
within the wider company. Not only is the QPPV a legal
and regulatory requirement for the MAH but, we believe, faced
with the complexity of the GVP modules, the QPPV role is necessary
to enable systems-based thinking to improve efficiency and to streamline decision-making. Ideally, safety and pharmacovigilance
should be the QPPV’s sole occupation, not an extra task in
addition to other functions. The skills required and the roles and
responsibilities for the QPPV are so numerous and varied that
he/she must delegate many tasks to deputies, managers and other
staff working within the organization. The QPPV, however, retains
accountability in that he/she must maintain oversight over
all delegated tasks and the entire pharmacovigilance system
What should a QPPV expect from the MAH?
Compliance with regulatory guidance for the QPPV depends
on unhindered cooperation with the MAH’s organization, which
in turn should visibly promote safety to underpin the QPPV role.
The MAH must openly acknowledge the importance of this role
for organizational success and ensure the views of the QPPV are
listened to and be seen to be taken into account. This may be
accomplished by:Making the position one of high rank in the organization
so the QPPV has the authority to act and remove barriers
Having regular meetings between the QPPV and the
chief executive officer and/or the board of the company
with regular presentations to the company’s senior
Ensuring that the QPPV function has the resources and
organizational support necessary to implement and
maintain a compliant pharmacovigilance system
Backing the QPPV when the going gets tough by
demonstrating trust and confidence.
Training the QPPV to develop the necessary skills in
leadership and delegation.
Providing educational opportunities to the QPPV so he
or she can continually seek best practices to improve the
efficiency of operation of the pharmacovigilance system.
Ensuring the QPPV receives regular briefings about benefit-risk information, and quality and performance
metrics concerning the pharmacovigilance system, as
agreed with the QPPV.
In return, the attributes required by the MAH of a QPPV might
Being held in high regard by peers regardless of “rank” as
a wise counsel — someone who “walks the walk” and not
just “talks the talk.” This applies both internally within an
organization and externally while networking.
Possessing knowledge and skills required for effective
oversight of a pharmacovigilance system with insight into
training needs, corporate culture, root cause analysis,
designing corrective actions and organizational learning.
A QPPV does not need to be a medical graduate but, if
not, must have ready access to a medical opinion. Indeed,
the key skills go way beyond medical and regulatory
knowledge typically associated with pharmacovigilance
to include skills around communication, organizational
ability and team-working .
Understanding what is required to identify and to correct
deficiencies in the system to acceptable standards.
Accessibility and the ability to put members of the
organization at ease so they feel they readily turn to the
QPPV for a reasonable and pragmatic opinion or advice
without fear of impulsive blame or unjustified adverse
Being an individual who promotes action, rather than
reaction, such as by setting up of training programs, audit
and gap-analyses, and supporting the implementation of
Being able to explain requirements regarding relevant
safety information for benefit-risk assessment and
current stakeholder expectations in pharmacovigilance.
Meaning of oversight
GVP Module 1 states that 'the QPPV has oversight over the
functioning of the system in all relevant aspects, including its quality
system….' However, the term oversight is open to interpretation
as there is no definition in legislation or guidance as to what
"oversight" means. The meaning is reflected in both the definitions
arising from two dictionaries as follows: "Merriam-Webster:
watchful and responsible care" and "Oxford English Dictionary:
The action of overseeing something". It may help to understand
in practical terms what oversight means, if we turn to other areas
where oversight is applied such as in government and public
services. In these sectors, oversight implies scrutiny of processes
and holding to account. From this we have concluded that there
are three possible components of "oversight" for the QPPV that
need to be discussed in the context of the pharmacovigilance
system: monitoring of processes, critically appraising policy and
practice and advising on improvement.
Need for change management skills and leadership
Standards for systems-based thinking and behavior are not
well-established in the pharmaceutical industry . Within
a pharmaceutical company, the responsibilities of the QPPV
impact multiple processes, departments, and professionals
who may perceive things differently and may have different
motivations and incentives. To be a successful QPPV requires
an understanding of systems, behavior change, and culture while
identifying the needs of the various stakeholders. This requires
leadership skills, which differ from but overlap with those of
management. The QPPV may be required to act as a manager in
one area where he/she may have line management responsibility,
whereas outside this area, the QPPV may need different skills to
achieve desired aims for the benefit of the system.
The art of delegation is essential for the QPPV function
GVP Module 1 states that 'The QPPV may delegate specific
tasks, under supervision, to appropriately qualified and trained
individuals, for example, acting as safety experts for certain
products, provided that the QPPV maintains system oversight
and overview of the safety profiles of all products. Such
delegation should be documented'. Furthermore, GVP Module II
concerning the Pharmacovigilance System Master File states that
'the list of tasks that have been delegated by the qualified person
for pharmacovigilance shall also be included in the Annexes (see
Delegation is inevitable for practical implementation of
the QPPV role. Not only could no single individual have the
time to directly perform all tasks required of the QPPV, but it
is also unrealistic to expect that any one QPPV to have all the
necessary skills and expertise. Standard Operating Procedures
(SOPs) and related documents are important for capturing the
details of delegation. In practice, delegation means empowering
someone else and giving them the freedom to act. However, as
the QPPV always remains accountable, there needs to be clear
understanding about what this implied transfer of authority
means. Delegation can be a powerful tool for motivation so how
this is done is critical. However what training is available for a
QPPV about how to delegate?
There are three main forms of delegation:
1. Delegation of responsibility. This refers to work that is
delegated, i.e. the job, the task and the duty.
2. Delegation of authority. This refers to the power or the
right to make and implement decisions to enable this
responsibility to come to a successful conclusion.
3. Delegation of accountability. For the QPPV this is not
possible as he/she is ultimately accountable for the
success or failure of the delegated responsibility for a
concerned job or task.
By combining 1 and 2, delegation is likely to be effective.
If responsibility is given without authority, then this is not full
delegation - one does not go without the other. The instructions
for such partial delegation need to be explicit.It is important to define and comprehend the essential
components of delegation before describing a general process
for delegating. For that reason, we have chosen description
model referred to as the Tannenbaum and Schmidt Continuum
(described in Table 1 below) as we believe this is easy to
comprehend. This model in Table 1 shows the levels of delegation
which refers to the relationship between the level of freedom to
act that a QPPV chooses to give to an individual, and the level
Table 1: Levels of delegation with corresponding implications
Level of Delegation
Implications of Each Level
"Wait to be told." or "Do exactly what I say." or "Follow these instructions precisely."
This means there is no delegated freedom at all from the QPPV who retains full oversight.
"Look into this and tell me what you come up with. I'll decide."
This means investigation and analysis but no recommendation.
"Give me your recommendation, and the other options with the pros and cons of each. I'll let you know whether you can go ahead."
This means analysis and recommendation, but with a check on the reasoning before decision.
"Decide and let me know your decision, but wait for my go ahead."
This means approval of the decision but the delegate is trusted to judge the relative options.
"Decide and let me know your decision, then go ahead unless I say not to."
Now the delegate controls the action but still requires approval. The subtle increase in responsibility may save time.
"Decide and take action, but let me know what you did."
This form of delegation saves more time while still allowing a quicker reaction to wrong decisions not present in fuller delegation.
"Decide and take action. You need not check back with me."
This gives full freedom to act to the delegate; a high level of confidence is necessary and the QPPV delegating would be expected to assess the quality of the activity according to the final outcome and be free to intervene at any stage should concerns arise.
"Decide where action needs to be taken and manage the situation accordingly. It's your area of responsibility now."
This is the greatest freedom that can be given to another person or team and normally requires a formal documented change in a person's job role. This gives the delegate responsibility for defining what projects and tasks are necessary for the management of a particular area of responsibility, as well as the task or project, and how it is to be done and how quality is to be measured. This would amount to delegating part of the role of QPPV - not just a task or project.
of responsibility retained by the QPPV . This may be of value
when categorizing delegated tasks in the Pharmacovigilance
System Master FileOnce a task is delegated, let the person or team get on
with it allowing them to have the authority to achieve it.
Where possible, the delegate should be allowed to own it
within agreed boundaries.
Introduce delegation of a new task or activity gradually.
Review a project on the agreed reporting dates without
looking over the delegate’s shoulder, so-called ‘micromanagement’.
Ensuring the delegates know how to perform task and are
aware of sources of relevant information and knowledge.
Give help and coach when requested because it is
important to support those you have delegated to when
they are having difficulties without doing the job for them.
Recognize that those who the QPPV has delegated to may
know a better way of doing something than the QPPV
does. This should not stop a QPPV from training said staff
in the standards he/she would apply so that expectations
Accept that there may be different ways of approaching
a particular task, and that one of the best ways of really
learning something is through making mistakes. The
QPPV should always respect those mistakes that are not
caused by idleness or recklessness and from which that
the delegate has visibly learnt.
When errors of concern arise, the QPPV should support
constructive analysis of the cause. The QPPV should
resist a superficially response and comment specifically
in terms of the actual events or circumstances, which
led to the error. The objectives of such an analysis can
be summarized as helping to ensure that those to whom
the task was delegated understand the problem and feel
confident enough to resume and to prevent recurrence.
Accept only what is agreed finished work although this
may be a ‘Draft’ if that is appropriate. Agree in advance
the criteria and standards by which the outcome will
be judged the deadlines for completion and internal
reporting dates when the QPPV wants information on the
progress of a project.
Give credit when a job has been successfully completed
with constructive feedback. Public recognition both
reinforces the enjoyment of success with those who have
been delegated to carry out a task and sets a standard for
As the individual’s freedom to act is increased according to
the level of delegation, so the QPPV’s responsibility decreases.
Regardless of different levels of delegated responsibility,
accountability remains with the QPPV. However, while a QPPV
can delegate as many tasks as possible, which can be effectively
carried out by others, the QPPV cannot delegate the control of the
system. Thus, effective delegation involves achieving the correct
balance between effective controls of work and letting people get
on with jobs in the best way they know how.
A QPPV needs to develop skills in diplomacy and negotiation to
reach agreement with delegates about what they should be doing
and the expectations linked to this responsibility. Depending on
where the expertise or competency lies, delegation can occur
downwards to juniors or upwards to senior staff, or even laterally
to peers. The QPPV should ensure that decisions are explained
to them so that the QPPV can understand the criteria on which
decision were based so that they are able to explain them to a
third party. Whatever the rank of the person within a company
to whom the QPPV has delegated a task, no one can reasonably
hold an individual responsible for some action to which they
have not agreed. As regards motivation, a person would be more
likely to be committed to delivering a responsibility if they have
been through the process of agreeing to do it and understand
its importance. This implies that delegates should be consulted
about expectations, such as time-scale, resources, budget even
the purpose and the method. Of course, certain responsibilities
relevant for the QPPV may have already been agreed implicitly
within a person’s documented job description or employment
Having allocated the different levels of delegation matching
tasks with individuals, we would advise The QPPV should
consider the following:
Delegation is not just a matter of telling someone else what to
do. It is primarily about entrusting authority from one person to
another. There is a wide range of freedom that can be conferred
on this other person. The more experienced and reliable the
delegate, the more freedom can be transferred. However, the
more critical the task, the more cautious one would be about the
extent of freedom on offer. It is important also to ask the other
person or team what level of authority they are comfortable with
accepting. Involving the delegate in agreeing the level of delegated
freedom for any particular responsibility is an essential part of
the ‘contract’ that is made with them.
One special role for delegation is the deputy QPPV. A
deputy is a person appointed or empowered to act for another.
However, there is no reference to deputy in the legislation and
no consensus as to what this role might involve. This means the
QPPV, in discussion with the MAH, must define what deputisation
involves including how many deputies would be appropriate.
Referring to other sectors of society, a deputy has the power to do
every act, which his principal might do, but a deputy cannot make
a deputy. A deputy should always act in the name of his principal.
The principal is liable for the deputy’s acts, and for neglect of the
deputy. One of the oldest and best established deputy roles which
is legally enshrined, is that of deputy sheriff who is designated to act on behalf of the sheriff in regard to official business or that of
a general deputy who has authority to execute all of the regular
duties of the office of sheriff and serves process without any
special authority from the sheriff.
The function of the qualified person responsible for
pharmacovigilance is appearing in other pharmacovigilance
legislation around the world and it remains to be seen whether
these roles will be interpreted and applied similarly to the EU/
EEA QPPV. These new roles accentuates the need for guidance
and a dedicated training program which was already well overdue
in view of the complexity of interactions within a company for
assessment of the benefit-risk of medicinal products throughout
their life-cycle, and for taking appropriate action. In addition to
understanding EU pharmacovigilance regulations and guidance
documents, the QPPV must decide how he/she can best apply key
activities such as oversight, leadership and delegation in order to
fulfill their obligations within the framework of the organization
for which he/she is responsible. Based on our experience, we
have provided an easily understandable model for delegation
with practical advice about implementation.