An interlocking set of values, communications practices, goals, processes, roles, attitudes and assumptions are included in the organization’s culture. We must understand our culture and choose and implement the cultural changes that support our aspirations.

1. Change an organizational
culture and
Pharmacovigilance
Baltzidis Anastasios, Qualified Person
Nicosia, 12-Sep-2015

2. Contents
What is an organization’s culture ?
The role of values, polices and behaviors
Managers and Employees role in Culture Change
How select a culture?
How the pharmacovigilance culture could change?
How implement the Cultural change
Case Study
Change an organizational culture and Pharmacovigilance | Anastasios Baltzidis | 12-Sep-2015 |
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3. Change an organizational culture and Pharmacovigilance | Anastasios Baltzidis | 12-Sep-2015 |
What is an organization’s culture ?
An interlocking set of values, communications
practices, goals, processes, roles, attitudes and
assumptions are included in the organization’s
culture.
We must understand our culture and
choose and implement the cultural
changes that support our aspirations.
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4.  We could think that Culture is a pyramid, the foundation
of which is formed from the values/beliefs of the
organization.
 Values and beliefs lead to policies/practices.
 Implementation of policies/practices results in the
culture-defining behaviors.
The role of values, polices and behaviors
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5. Behaviors
Policies
Values
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The culture pyramid

6.  The employees reflect the attitudes and values
exemplified by their managers and supervisors.
 To change an organization’s culture, we must change
the example set by the organization’s leadership.
Managers and Employees role in Culture Change
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How select a culture?
 A culture supports the organization's aspirations.
 Examples of cultures: “customer-centric” or “people first”
or “one team” or “achievement” culture
 The process is:
 identify the desired culture ex. patient safety
 identify the values that support the desired culture
ex. integrity, quality, innovation, responsibility
 culture and values must be aligned with business
behaviors, symbols and systems.
A Safety “Customer Centric” culture is a
pharmacovigilance culture!

8. How the pharmacovigilance culture could change?
 The goal of the organization must being crystal clear
ex. “Patient Safety first”
 At every opportunity communicate this goal
ex. Any product of the company must be safe at the
patient level before commercialization!
 Holding people accountable to their contribution to the goal
ex. People accountable for “Patient Safety first”
 Distilling the goal into discrete outputs for teams
ex. Commercial, Regulatory, Safety, Medical teams
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9. How the pharmacovigilance culture could change?
(cont’d)
 Training and promoting from within
ex. adverse event reporting, risk management plan
 Πείτε ιστορίες που συμβάλλουν στην επίτευξη αυτού του
στόχου
ex. Safety patients stories
 Owning up to mistakes and poor outcomes to change the
outcomes
ex. Safety Patient responsibility and accountability
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10. How implement the Cultural
change
“Culture eats strategy for lunch”
Peter Drucker

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Level 4: Leadership
reflect and support
change
Level 3: Organize
Business to support
change
Level 2: Organize
actions to
implement change
Level 1: Align
culture and
business strategy
A four levels implementation process

12. Level 1: Align Culture and Business Strategy
 Level 1 sets a firm foundation for change
 Define what kind of organization do we need to
become in order to become part of the business
DNA.
 Established and implemented vision, mission, values
and behaviors that align and reinforce the strategic
direction of our business.
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13. Level 2: Organize actions to implement change
 Level 2 communicates the style of the new culture.
Active communication is an essential component of
any culture change programme.
 Staff receive targeted communications that build a
compelling case for change and highlight benefits and
dis-benefits.
 These initial two levels will not in themselves deliver a
strategy for long-term change. In fact, there is still no
real incentive for staff to do anything differently and
commit to the change process.
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14. Level 3: Organize Business to support change
 Level 3 must reinforce those changes at a business
level. The Human Resources policies and procedures
must align to the requested change.
 Staff understand what needs to change and why.
 Human Resources policies and procedures will speed
up the culture change process and ensure that
changes are embedded within the business.
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15. Example of actions to implement change actively:
 Dealing with staff members who resist to the change
 Performance management about the change
 Reward and recognition related to change
 Promotion (s) which support change
 Recruitment (s) which support change
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Level 3: Organize Business to support change

16. Level 4: Leadership reflect and support change
 The leaders of the organization do actively sponsor and
support the process. Leadership is by far the strongest
lever of cultural change
 Achieving cultural change is a difficult and lengthy
process but it can be achieved with adequate leadership
resolve.
 The leaders in business exemplifying the values,
capabilities and behaviors they want their staff to
demonstrate. Leaders must adopt a ‘do as I do’ way of
behaving.
 ‘Do as I say’ sabotages the success of culture change.
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17. “A successful person is one who can lay a firm foundation
with the bricks that others throw at him.“
David Brinkley
Culture change process
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Case Study: McNamara (World Bank President 1968-
1981)
He didn’t change the managers or bring in his own
staff. He basically worked with people who were already
there. When he needed something he couldn’t get from
the existing management, he drew on young people from
within the organization.
He didn’t start by reorganizing: It was only four years
after his arrival (in 1972) that McNamara finally got
around to a reorganization, which was needed in any
event because the organization had grown so much.
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