Healthcare Compliance Officer
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.
Qualifications:
EU Bachelor Degree (Master degree is a plus). Advanced EU Healthcare Compliance certification.
A senior compliance executive with 6+ years of experience in healthcare compliance gained in the EU Pharma/Biotech industry/life sciences sector. At least, experience as senior compliance officer 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.
Experience of international healthcare compliance in Pharma/Biotech healthcare compliance practices outside of EU and the US, preferably including the APAC region, will be 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
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