Compliance Associate

At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity.

With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products.

All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs.

Our Principles:

The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team.

Purpose of the Job:

• supporting and conducting local investigations as assigned by the LCO and RCO (at least 60-70% subject to caseload),
• conducting event monitoring activities and spot checks,
• conducting Business Partner Due Diligence (BPDD),
• supporting the LCO in other relevant tasks as assigned, such as daily compliance advisory, facilitating culture awareness, spot audits, creating regular reports and presentations, training materials, and research on local legal and compliance topics.

Responsibilities:

Investigations Support (core responsibility):

• Support the LCO on handling compliance cases in accordance with FKs Case Management SOP, under the supervision and guidance of the LCO and RCO.
• Open and log cases and whistleblower reports on the Case Management System (NAVEX).
• Conduct pre-assessment by analysing complaints and whistleblower reports and identify key compliance issues and evidential leads for further investigative steps.
• Liaising with key informants such as whistleblowers, and/or other business and functional teams which have information relating to the pre-assessment and the investigations
• Prepare for investigations by drafting interview questionnaires, gathering and organizing evidential materials, and structuring a game plan and briefing the LCO and RCO on investigative strategies before proceeding to interviews.
• Conduct investigations by performing document review, samples check, data analysis, e-Discovery and subject interviews.
• Lead and/or support investigative interviews by questioning subjects of investigation and taking minutes for the interview.
• Travel to office locations and/or other vendors to conduct a site visit to gather evidence.
• Keep a good record of investigative steps and ensure a timely update on the Case Management System.
• Write up pre-assessment conclusion (in case the matter does not lead to formal investigations) and investigation reports (in case the matter results in an investigation).
• Suggest and follow up on remedial actions (e.g. disciplinary actions, process improvements, training) following from the findings identified in investigations.

Monitoring Activities and Spot Checks:

• Under the supervision and guidance of the LCO, conduct monitoring activities and spot checks on business/promotional activities and interactions with Healthcare Professionals (HCP) and Healthcare Organization (HCO).
• Plan and design a plan for monitoring activities, detailing dates, time, frequency, sampling criteria, and mode of monitoring for Product Promotion Activities (PPA) and Continuous Medical Education events (CME).
• Conduct regular event spot checks, both on-site and remote, as planned, on PPA and CME, and record the monitoring observations (and create a template with the LCO for such report)
• Conduct post-event/reimbursement sample checks to verify whether documentation is provided sufficiently and according to defined standards, and record the monitoring observations (and create a template with the LCO for such report)
• Monitor the event spend against pre-defined soft caps (monetary thresholds), alert the LCO and business in case certain activities are about to exceed the soft caps.
• Apply knowledge from investigations to update and enhance the monitoring activities to ensure they stay relevant and address the key risks as identified.
• Suggest continuous improvement and explore ideas of technology and IT applications to improve the efficiency and effectiveness of monitoring activities.

Business Partner Due Diligence (BPDD):

• Conduct Business Partner Due Diligence, as supervised and delegated by the LCO.Ensure all required documentation is compiled in BPDD request.
• Review and check information provided in BPDD Questionnaires.
• Conduct a search on BP on the Compliance Catalyst tool and document results.
• Conduct public media search on BP (e.g. Google, or other searching engines/platforms as applicable in India)
• Generate awareness and train employees on the BPDD process
• Monitor BPDD validity and liaise with business or functional teams to ensure BPDD remain all up to date.

  Support LCO on other CMS tasks as assigned:

• Under the supervision and guidance of the LCO, provide daily advisory to business and functional colleagues.
• Generate awareness and help foster a compliance and speak-up culture, e.g. in local Compliance Ambassador programme.
• Assist the LCO in generating compliance content such as training materials, compliance reports to local management, Regional and Global Compliance, and risk assessment etc.
• Assist the LCO in preparing for and supporting various audits, external or internal.
• Monitor local legal environment and conduct research on local laws and regulations, industry codes, e.g. UCPMP Code, Drugs and Cosmetics Act, and Data Privacy guidelines etc.
• Take on other tasks as assigned by the LCO or RCO from time to time.