Healthcare Compliance Officer

 

About Pharming
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases.  Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development.  Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

The role:
The Healthcare Compliance Officer strategically partners with and advises the business, including the Commercial, Marketing and Medical teams and their senior management,  to ensure that Pharming acts in an ethical manner and is compliant with all healthcare-related rules, regulations and practices applicable to its operations in Europe and the rest of the World, including compliance with rules and regulations applicable to the development, testing, launch, marketing and distribution of therapies and products. In doing so, the job holder, plays a pivotal role in fostering and promoting a culture of ethics and integrity across the global Pharming organization.


 

Areas of responsibility:

  • Strategically partners with and advises the business, including the Commercial, Marketing and Medical teams and their senior management, to ensure compliance with all healthcare-related rules, regulations and practices applicable to the Pharming operations in Europe and the rest of the World, including without limitation compliance with rules and regulations applicable to the development, testing, launch, marketing and distribution of therapies and products and to interactions with HCPs, government officials, payers, patients, patient organizations and other healthcare stakeholders. 
  • The Healthcare Compliance Officer is a member of the team of Healthcare Compliance Officers for the EU and RoW. Within the team, each of the Healthcare Compliance Officers acts as a designated subject matter expert/centre of excellence and is the primary point of contact, for specific allocated matters in the field of healthcare compliance.  
  • Together with the other Healthcare Compliance Officers, contributes to the design, implementation, maintenance and monitoring of the elements in the Global Business Integrity program related to healthcare compliance in the EU and the RoW with the objective to prevent, identify, mitigate and manage ethics and compliance risks for Pharming. The activities covered include, amongst others, the development, implementation and monitoring of healthcare compliance-related systems and processes (such as the third-party process, the policy management system, the learning management system, approval process systems), company-wide and business-specific policies, procedures and practices and training programs.
  • Together with the other Healthcare Compliance Officer and as directed by the Sr Director Corporate & Healthcare Compliance EU & RoW, contributes to effective compliance risk assessment and management, trend analysis and root cause analysis, each time with a primary focus on healthcare compliance in the EU and the RoW, by:

          o    designing, implementing and testing adequate internal controls; 

          o    driving and overseeing the monitoring plan, including following-up on monitoring results, analyzing trends and root causes, contributing to remediation plans, and updating policies and processes, if necessary; and
          o    participating in healthcare compliance-related investigations. 

  • Together with the other members of Business Integrity, coordinates the Intranet page of Business Integrity. 
  • Co-drives business integrity governance, including via effective business integrity committee meetings.
  • Reports on a regular basis, and without undue delay in case of incidents, to the Sr Director Corporate & Healthcare Compliance EU & RoW and, whenever appropriate, the Chief Ethics & Compliance Officer and management, on the business integrity risks related to healthcare compliance in the EU and the RoW.
  • Monitors developments in healthcare and corporate rules and regulations and compliance practices in the EU and RoW relevant to Pharming. Regularly educates and informs the business, senior management and other staff members, together with the other team members, on matters related to the compliance program as well as relevant healthcare industry legal and compliance developments.

 

 

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

  • A highly competitive salary
  • 8.33% holiday allowance (for NL)
  • A minimum of 30 vacation days
  • An excellent pension plan
  • Commuting allowance

 

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.

Also important! We truly value a healthy life-work balance with a lot of flexibility.


Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.