Sr. Director Corporate & Healthcare Compliance
The role:
The Sr Director Corporate & Healthcare Compliance EU/RoW (hereafter: the “EU/RoW Senior Compliance Director”) leads the healthcare compliance operations for Pharming in Europe and the rest of the world. In that capacity, the EU/RoW Senior Compliance Director builds and manages a team of senior compliance officers and strategically partners with and advises senior management to promote and ensure that Pharming acts in an ethical manner and is compliant with all applicable healthcare-related rules and regulations.
The EU/RoW Senior Compliance Director also has a leading role in (i) ensuring compliance with applicable rules and regulations in the field of data protection/privacy and (ii) developing, implementing and maintaining corporate law-related policies and controls to ensure that Pharming is compliant with all rules, codes, and regulations applicable to it as a company listed in both the Netherlands and the US.
In doing so, the EU/RoW Senior Compliance Director, as a senior executive, plays a pivotal role in fostering and promoting a culture of ethics and integrity across the global Pharming organization.
Areas of responsibility:
Leads and oversees the healthcare compliance operations for Pharming in Europe and the rest of the world (“RoW”), building and managing a team of (initially, three) senior compliance officers. Also leads the activities across Pharming aimed at ensuring that Pharming is compliant with all applicable rules and regulations in the field of data protection/privacy, including the GDPR. The Privacy Officer also reports to the Sr. Director Corporate & Healthcare Compliance EU/RoW.
Together with the Sr Director Healthcare Compliance US, responsible for the design, maintenance, implementation and monitoring of an effective Global Business Integrity program for Pharming, to be adopted by the Executive Committee, (i) to enhance an ethics and compliance-oriented culture across the organization, and (ii) to prevent, identify, mitigate and manage ethics and compliance risks. This program includes the development of global compliance policies, procedures and practices and the design, implementation and monitoring of compliance-related systems and processes.
Leads and manages for the EU and the RoW the implementation, maintenance and monitoring of the Global Business Integrity program, as adopted by the Executive Committee, including, inter alia the design, development and implementation, to the extent required, of specific, tailor-made policies and procedures for the Pharming operations in the EU and RoW in accordance with the global policies and procedures, the execution of monitoring activities and the execution of the related training programs for management and staff.
Strategically partners with and advises senior management of Pharming, and oversees effective advice and other support activities by team members regarding specific files and projects, to promote and ensure that Pharming acts in an ethical manner and is compliant with all applicable healthcare-related rules and regulations governing its operations in Europe and the RoW, including, inter alia, sales, marketing and medical activities.
Strategically partners with and advises senior management of Pharming to ensure compliance by Pharming with all Dutch and US corporate-law related rules, codes, and regulations applicable to it as a listed company.
Executes the tasks, responsibilities, and powers as attributed to the Compliance Officer by and under the prevailing Internal Code on Inside Information and Reporting Obligations (hereafter the “Insider Code”) and other applicable policies.
Monitors and executes the notification responsibilities to regulatory authorities (including the AFM and the SEC, as the case may be) applicable to Pharming, as listed company, and members of the Board of Directors and the Executive Committee.
Contributes to effective compliance risk assessment and management, trend analysis and root cause analysis for the EU and RoW, by:
- implementing and testing internal controls in accordance with Pharming’s global business integrity program;
- designing, implementing and testing adequate internal control (including those required for SOX compliance);
- 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;
- supporting process reviews and implementing improvements through system integration and data analytics in alignment with Pharming’s Global Compliance strategies; and
- conducting compliance-related investigations, including those as identified in the Alert Reporting Procedure, the Insider Code and other applicable internal policies.
Reports on a regular basis, and without undue delay in case of incidents, to the Chief Ethics & Compliance Officer and senior management on the existing and emerging business integrity risks.
Monitors developments in healthcare and corporate rules and regulations and compliance practices relevant to Pharming. Regularly educates and informs senior management and other staff members, together with team members, on matters related to the compliance program as well as relevant healthcare industry legal and compliance developments.
Manages budget resources assigned to Business Integrity for the EU and RoW.
Member of the Pharming Disclosure Committee.
Qualifications:
EU Master’s Degree. Advanced EU Healthcare Compliance certification.
A senior compliance executive with 12+ years of experience in healthcare compliance gained in the EU Pharma/Biotech industry/life sciences sector, including 5+ years of management experience. At least, executive experience in the following areas: bribery and anti-corruption regulations, HCO/HCP/HCC regulations and practices, transfer of value/transparency reporting/FMV processes, Due Diligence processes, promotional activities, speaker programs, advisory boards, HCO sponsorships and grants and donations.
Both healthcare compliance experience gained in the rare disease segment and experience regarding pharmaceutical product launches will be a plus.
Expert knowledge of prevailing EU healthcare compliance standards and practices, including EFPIA code requirements and standards.
5+ experience of international healthcare compliance in Pharma/Biotech healthcare compliance practices outside of EU and the US, preferably including the APAC region.
3+ experience with listing requirements gained at a European (preferably Dutch) listed company, including expert knowledge of the EU market abuse regulations. Expert knowledge and experience of US (SEC and Nasdaq) listing requirements is a plus.
Flexibility as well the ability to work effectively in a senior compliance role in global cross-cultural and cross-functional teams.
High risk awareness and risk management skills
Proficient in Microsoft Office
Languages: English: fluent; Dutch: a plus.