Senior Manager, SOM Investigations & Due Diligence

ROLE SUMMARY

Global Security (GS) provides leadership in the development and implementation of security policies and programs to protect the Company's personnel, real and intellectual property, reputation, and the integrity of our medicines, upon which the public relies to live happier and healthier lives. In pursuit of that mission, GS monitors the irregular and excessive distribution of Pfizer controlled drugs to prevent and deter abuse in the marketplace. The opioid epidemic has caused increased industry pressure to revamp compliance and enforcement to the Controlled Substance Act and provide transparency in the regulation of the supply chain. To that end, The Drug Enforcement Agency (DEA) launched the Suspicious Orders Report System (SORS) to log and track the reporting of all suspicious controlled substance orders. Registrants will be required to report suspicious order and what steps the registrant took to determine whether the order was for legitimate purposes. Continued compliance with DEA and state regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.

As part of Pfizer's Controlled Substance Ordering System (CSOS), the company is seeking to hire a Suspicious Order Monitoring (SOM) Senior Manager to develop a comprehensive control substance due diligence program according to DEA's Know Your Customer guidance and conduct investigations to prevent and diversion. The SOM Manager will coordinate efforts closely with Global Supply, Legal, Compliance, Trade and other stakeholders within the organization; and build a collaborative relationship with DEA, US Food and Drug Administration (FDA), authorized distributors, and other external agencies to minimize risks associated with diversion and abuse outside of Pfizer's supply chain. The successful candidate will be responsible for the overall management, operation, and maintenance of the SOM due diligence program; conduct analysis of controlled substance orders for trends; conduct audits of customers who purchase control substances; establish a repository for due diligence responses; author policy and guidelines for successful compliance to the CSOS and investigate suspicious order to assist management with distribution and shipping decisions. High level investigations may require briefing to senior management.

This role requires the building of collaborative relationships with colleagues from the Global Supply, Trade, Legal, Business Technology, customer service and other platform services to facilitate the documentation of the investigation and CSA reporting process. Experience in audit and investigation is vital as well as a practical understanding of the CSA, SOM, and CSOS. An advanced understanding of software programs, such as Microsoft Excel l and PowerPoint are vital. The candidate in this role will also create a vision for the future of the SOM program and will work with the company's data warehouse to develop processes for advanced analytics to improve reporting capability to create a deterrent.

This position will report directly to the Senior Director, Global Fraud, Diversion, and Asset Protection.

ROLE RESPONSIBILITIES

• Manage all overall aspects of the company's control substance due diligence program and leverage analytical tools to monitor the distribution of controlled substances from Pfizer distribution centers to its customers.
  
• Conduct timely and thorough investigations of suspicious orders to detect diversion and develop a process to monitor orders outside the SOM algorithm.
• Direct and coordinate on-site inspections of Pfizer customers to verify compliance with DEA regulations, standard operating procedures and best practices.
• Develop a sound plan for evaluating all sources of SOM data for potential diversion trends and make recommendations for corrective actions.
• Develop processes and analytics to use distribution data to trend and track control substance transactions in order to detect and remediate suspicious customer orders.
• Assess the potential risks to Pfizer as it relates to customers purchasing unusual orders of controlled substances for their stated business model.
• Maintain a strong relationship with Pfizer Global Supply to ensure an accurate understanding of control substance monitoring and then build controls to strength deterrence.
• Lead in a matrix and in partnership with US Trade, Global Supply, and Digital to identify the areas the risk for diversion of controlled substances is high and create measures can reduce risk and ensure Pfizer is within a compliant state.
• Develop processes that create a deterrence and minimizes risk of downstream diversion through analysis and trending of controlled substance orders.
• Remain abreast of new policies and recommended guidance to ensure compliance to CSA and SOM regulations, share the results with the Working Group, and develop a DEA engagement strategy.
• Collect evidence and facts related to the suspected diversion or abuse of controlled substances and document those findings in a manner where such documentation will have analytical value to assess future trends.
• Develop due diligence process to "know the customer" to enhance decision making around suspicious orders.
• Track and report SOM results on a regular basis and communicate program metrics to leadership.
• Responsible for the development and monitoring of verification strategies to detect fraud;
• Ensure 'best in class' program integrity processes, infrastructure and tools are utilized to accurately identify and manage product diversion risks.
• Develop an effective program to educate and update customer service and other stakeholder on practices to detect and deter diversion.
• Consult with business unit managers on strategies to prevent diversion and drive effective results considering the needs and priorities of the business units.

BASIC QUALIFICATIONS

• Bachelor's Degree in related field.
• Minimum of 7 years of related industry experience, including experience in conducting audits and diversion investigations.
• Must have sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders
• Previous experience in leading / conducting pharmaceutical diversion investigations .
• Previous experience in interpreting government regulations and applying results to corporate compliance.
• Comprehensive/Working knowledge of DEA regulations with emphasis on Schedule II and all other controlled drugs and listed chemicals.
• Experience interacting with State and Federal regulatory officials.
• Ability to analyze and troubleshoot issues and develop CAPAs.
• Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met.
• Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
• Skilled at preparing and analyzing big data spreadsheets and charts.
• Competent writer of corporate policies and communications.
• A strong knowledge of big data analytics and implementing fraud control measures in a corporate environment.
• Individual must possess excellent written and oral communication skills.
• Demonstrates the ability to work collaboratively and effectively at all levels of the organization.
• Individual must be an effective change agent with highly developed problem-resolution skills.
• Good organizational skills with the ability to work independently and initiate proactively.
• Fluent skills in Microsoft Word, PowerPoint, Excel and Access. Must have previous experience in working with pivot tables
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Preferred Qualifications

• Master's degree or related professional certification such as CPP.
• Law Enforcement / Legal / Investigations experience.
• Knowledge of working in SAP.
• Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
• Knowledge and experience in DEA required records (e.g. DEA Forms 222, 263, 357, 161, etc.).
• Previous experience in a SOM role..
• Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations.
• Experience working in pharmaceutical industry.
• Experience with managing SOM analytical software.

PHYSICAL/MENTAL REQUIREMENTS

Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This is an exempt position
• This position can be onsite in PA/NY/NJ
• 20% travel is expected
• Global Security is a 24/7/365 responsibility for the company. While the average work week will entail 40 hours of work during a standard Monday to Friday work week, the successful applicant will be expected to be available after hours and on weekends to address and manage threats to the company or its employees while also reporting outcomes to management.

OTHER INFORMATION

• Last Date to Apply for Job: February, 4, 2021
• Additional Location Information: Collegeville, PA; Peapack, NJ; New York, City
• Eligible for Employee Referral Bonus
• Eligible for Relocation Package: No

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