Subject Matter Expert

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Date: Sep 18, 2023

Location: JP

Company: ArisGlobal

Company Description

The mission of ArisGlobal is to empower life science organizations to deliver breakthroughs faster, more accurately, and with greater precision. ArisGlobal's software, services, and technologies are essential to the delivery of life-saving medications. As an industry leader, ArisGlobal offers software as a service for Clinical Trials, Regulatory Affairs, Drug Safety, and Medical Affairs. Our products are utilized by 40 out of 50 major biopharmaceutical companies. Among our clients are four out of five of the world's most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada, and the National Medical Products Administration.

ArisGlobal proudly boasts offices in Boston, Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, and Mysore, our global presence is clear, and we are growing faster than ever. At ArisGlobal, we are distinguished by the high caliber of our team and by our passion for creativity and innovation. We pride ourselves on our welcoming and supportive corporate culture, which is inclusive of all Team Members. Our challenging projects are complemented by flexible work locations and competitive salaries.

About Role

The Subject Matter Expert will support the company’s primary goal of expanding revenue and revenue opportunities by amplifying the Global Service Delivery (GSD) departments’ capabilities to address topics of special expertise, current events, and industry trends. The best fit for this role will have consulting experience, a technical background, knowledge and time spent working in Drug Safety & Pharmacovigilance + exposure to cloud-based solutions + SaaS.


  • Customer facing: During discussions with potential customers, bring to bear extensive knowledge of the field, and explain not only how our products would suit them, but what they should be doing relating to drug safety, etc. Assist clients in overcoming the resistance in the industry to certain techniques, partly cultural and partly regulatory in origin and assisting them in navigating through their concerns is an essential component. Lead Business Development activities (e.g. Workshops) on our customer projects.
  • Inward facing: Internally, this position will provide direction to help develop and design software tools so that they function appropriately. Working with different individuals involved, assist in the ongoing projects related to the Safety suite as well as the creation of new offerings in the area of risk management. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support drug safety committees in their decision-making. The SME will be responsible for identifying and maintaining relationships with development partners and monitoring the development process of these strategic extensions.
  • Industry/agency thought leadership: This position will liaise with agencies on behalf of customers who might be particularly reserved about certain issues, and it is useful to be able to make thoughtful experienced arguments. At the same time, we would like to establish in industry forums (through speaking, writing, etc.) knowledge of Aris Global as setting the standard for how drug safety and pharmacovigilance should be conducted in terms of industry best practices. The best practices in many cases do not exist, but customers are eager for knowledge about ‘how others do it right’. We can convey that and help to establish the best practice where it does not yet exist. Prepares and delivers subject matter presentations, white papers, training, etc.

Required Education and Experience

  • Bachelor degree or master degree preferred.
  • Japanese Language proficiency required Business Level
  • 10 years Drug Safety or Pharmacovigilance combination of life science plus consulting OK.
  • Experience working with large administrative or medical records databases required prefer candidates with current statistical programming expertise.
  • Experience working with health authorities is preferred the successful candidate will be expected to stay current with the FDA and other Regulatory Agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools.
  • System implementation experience preferred.
  • Global experience preferred.
  • Authored in the subject preferred.

Preferred Qualifications

  • SaaS experience a highly preferred.
  • Strong industry awareness (Life Science - pharmaceutical software).
  • Proven excellent interpersonal and communication skills.
  • Effective time management & multi-tasking skills.
  • Ability to analyze and relate customer issues/requirements to ArisGlobal solutions.
  • Proven ability to influence cross-functional teams effectively.
  • Self-managed, self-starter, able to work in a rapidly changing environment.
  • High energy, detail-oriented and creative individual.
  • Ability to work both independently and cohesively in a team environment.
  • Excellent communication skills both written and verbal required.
  • Expertise in statistical software.