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Sr Manager, Global Suspicious Order Monitoring (SOM) & Analytics Leader

Employer
Pfizer
Location
Remote, Remote, United States;
Salary
Competitive
Closing date
Dec 11, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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ROLE SUMMARY
  • The Global SOM (Suspicious Order Monitoring) & Analytics Leader is a professional in the pharmaceutical industry who, as a result of educational and/or regulatory experience with controlled substances possesses the knowledge and skills necessary to provide coordination and management in Global SOM requirements and controlled substance metrics reporting.
  • The Global SOM & Analytics Leader oversees activities related to Suspicious Order Monitoring including vetting of new and existing Pfizer controlled substance customers, analysis of controlled substance orders for trends, investigation of orders of interest, as well as providing guidance for the reporting of suspicious orders to government agencies for all markets outside of the U.S.
  • The Global SOM & Analytics Leader also conducts and documents monthly reviews of U.S. SOM investigation reports for completeness and accuracy. Responsible for providing feedback on improvement of the U.S. SOM monitoring and investigation process and works closely with multiple departments within the global organization and other professionals outside of the organization to minimize risks associated with diversion outside of Pfizer's supply chain.
  • The Global SOM & Analytics Leader monitors changing global regulatory requirements related to SOM and provides comments to competent authorities during comment periods while regulations are under review. Responds to requests from government authorities related to suspicious order reports and investigations. Makes recommendations to SOM Oversight Committee for customer actions when and if required.
  • The Global SOM & Analytics Leader manages the metrics and Dashboard reporting for controlled substance activities globally. These metrics are used to track and trend controlled substance activities across the network.
  • Continued compliance with controlled substance 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.


ROLE RESPONSIBILITIES

Suspicious Order Monitoring
  • Directs and coordinates vetting of ex-U.S. Pfizer customers to verify compliance with in-country regulations, standard operating procedures and best practices.
  • Evaluates all sources of global SOM data for potential diversion trends and makes recommendations for corrective actions, if necessary.
  • Minimizes risk of downstream diversion outside of the U.S. through analysis and trending of controlled substance orders.
  • Provides guidance and oversees thorough investigations of ex-US orders of interest and ensures timely completion.
  • Reports ex-U.S. SOM program metrics to management.
  • Conducts periodic review of algorithms and thresholds in the ex-U.S. automated order review system.
  • Conducts SOM training for CSCF team members and other groups responsible for SOM compliance globally.
  • Reviews and approves SOM Requirements and SOPs related to Suspicious Order Monitoring.
  • Audits Global SOM system for compliance.
  • Monitors global SOM industry trends, best practices and guidance and adjusts program accordingly.
  • Conducts monthly reviews of the U.S. SOM investigation reports for completeness and accuracy.
  • Makes recommendations for program improvement.
  • Interacts with government authorities globally in reporting suspicious orders or in answering inquiries.


Analytics
  • Manages the process to track controlled substance metrics in Tableau.
  • Creates and maintains a controlled substance Dashboard for key performance indicators.
  • Publishes and presents metrics for CSCF monthly meetings and ad hoc meetings as requested.
  • Makes recommendations for additional metrics reporting that may be useful for the group, including leading performance indicators.


BASIC QUALIFICATIONS
  • Bachelor's Degree in related field with 7+ years of related industry experience OR
  • Master's Degree in related field with 6+ years of related industry experience.
  • Experience working in pharmaceutical industry.
  • Experience in conducting SOM audits and investigations is required.
  • Must have sound knowledge of product lines and associated indications to effectively facilitate communication with stakeholders.
  • Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions is necessary.
  • Must possess ability to think strategically, strong attention to detail and ability to problem solve.
  • Must operate with highest level of integrity, professionalism and exhibitsound judgement at all levels.
  • Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook).
  • Strong oral and written communication skills.
  • Comprehensive/Working knowledge of controlled substance regulations with particular emphasis on Suspicious Order Monitoring.
  • Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations.
  • Knowledge and experience in conducting CS investigations.
  • Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions.
  • Knowledge and experience in reviewing CS SOM SOPs to ensure CS requirements are met.
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
  • 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 preferred.
  • SAP knowledge.
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
  • Regulatory experience.


PHYSICAL/MENTAL REQUIREMENTS
  • Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • May require some travel (approximately 10%)
  • Work Location Assignment:Remote


Last Day to Apply: 09 DECEMBER 2022

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

#LI-Remote #LI-PFE
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