Change an organizational culture and pharmacovigilance

Change an organizational culture and

Pharmacovigilance

Baltzidis Anastasios, Qualified Person Nicosia, 12-Sep-2015

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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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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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

Change an organizational culture and Pharmacovigilance | Anastasios Baltzidis | 12-Sep-2015 | 4

Behaviors

Policies

Values


The culture pyramid

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



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!


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



(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


How implement the Cultural change

“Culture eats strategy for lunch” Peter Drucker


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

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.


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.


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.


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


Level 3: Organize Business to support change

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.


“A successful person is one who can lay a firm foundation

with the bricks that others throw at him.“

David Brinkley

Culture change process



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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Change an organizational culture and pharmacovigilance

Self Improvement

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