Human Resources Role in Pharmaceutical Company Compliance

Human Resources (HR) and Compliance share a common goal of facilitating,

monitoring, and enforcing employee compliance. However, in many
pharmaceutical companies, the two organizations often find themselves at odds.
With the increasingly high stakes attached to compliance, these two
organizations should break down barriers, forge stronger ties, and support each
other.
Before the advent of Compliance departments, HR traditionally handled
employee complaints, compliance issues, and dismissals. Consequently,
Compliance and its enterprise oversight role may be perceived by HR as more of
an interloper than a business partner. The key to improving the relationship is
consistent and frequent communication between the HR and Compliance
departments.
The prevalence of corporate integrity agreements, qui tam suits, harassment
complaints, and other employee-related compliance issues makes it important
that HR and Compliance work together more effectively than they have in the
past. Here are some focus areas for both HR and Compliance:
1. Let HR do its job but keep Compliance in the loop.
If an employee has a potential problem/issue, they typically take it to their
manager, who contacts HR, or they go directly to HR. While a majority of
employee matters do not involve compliance issues, HR should be sensitive to
what constitutes a possible compliance concern and, if one is raised, work with
Compliance to determine how best to follow-up and address the matter. As part
of this process, HR should understand the companys non-retaliation pledge for
employees who bring forth good faith complaints and understand what
retaliation might look like. Although SOPs are established for this process,
strengthening the relationship between HR and Compliance through training and
communication are helpful in building awareness and an efficient and effective
process.
2. Standardize employee job descriptions.
Creating and maintaining standardized job descriptions are important for both
HR and Compliance. For HR, standardized job descriptions make it easier to fill
positions on a more consistent basis and reduce workforce complexity. For
Compliance, standardized job descriptions facilitate the development of a
compliance training curriculum and a robust training completion monitoring
program. Also, in the case of Corporate Integrity Agreement (CIA) negotiations,
these job descriptions can help to determine which employees may be subject to
the CIAs requirements (e.g., covered persons). However, getting to that stage
in many pharmaceutical companies requires significant effort on the part of the
HR department to develop the framework for categorizing job descriptions and
then mapping legacy job descriptions to the new framework. This will help
companies ensure that the new job descriptions contain all essential elements of
the old ones.
3. Promote disciplinary equitability.
A key element of the Compliance Officers role is to help ensure that disciplinary
actions are fair and equitable throughout the organization. This necessitates

that HR, Compliance, and Legal collaborate when developing the companys
disciplinary policies, engage in an ongoing dialogue to review proposed
disciplinary actions, and ensure that corrective measures are appropriately and
consistently applied, regardless of an employees grade level.
4. Establish a collaborative monitoring and reporting process.
HR and Compliance should jointly develop a monitoring and reporting process for
investigations and disciplinary actions, and incorporate process metrics into
reports for the companys Compliance Committee, Senior Management, and
Board of Directors. In many cases, neither Compliance nor HR has the complete
picture of all matters involving policy breaches. Only by combining information
can the company gain a more comprehensive view of the types of policy
breaches that occur and their frequency. Also, the system should track open
investigations, matters that were determined to be unfounded, and matters
where discipline has been imposed.
5. Leverage resources.
A pharmaceutical companys HR and Compliance collaboration makes sense from
a sheer resourcing perspective. In most organizations, the HR organization is
significantly larger than the Compliance team. As such, HR has the ability to
cover more territory and to help Compliance stay abreast of potential issues by
providing additional eyes and ears throughout the company. Similarly,
Compliance can assist HR by providing specialized investigative, monitoring, and
training services. If the two departments can break through historic barriers to
collaboration, they may be able to greatly strengthen the HR and Compliance
processes company-wide.
Source : pharmacompliancemonitor.com
Recommended by :
CHRISTOPHER T. ANDERSON, SPHR, CBS
Vice President, Human Resources
Mlnlycke Health Care, Atlanta, GA
email: ctanderson209@sbcglobal.net
https://www.linkedin.com/in/chrisandersonsphr
Mlnlycke Health Care, Abbott Laboratories, Hospira Inc., Hill-Rom, The Ertl
Company
Pharma, Pharmaceuticals, Biopharm, Biopharmaceuticals, Medical Devices,
Biotech, Biotechnology

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