IBM Watson Health – Subject Matter Expert, Offering Management in CAMBRIDGE, Massachusetts

Job Description

We are seeking a talented, highly motivated and experienced pharmacovigilance Subject Matter Expert (SME) to join our fast-paced company. The primary responsibilities of the SME for Watson Health’s drug safety monitoring product(s) will be to provide the industry and operational expertise necessary to establish and maintain Watson’s cognitive computing, cloud and predictive analytics products focused on pharmacovigilance. The ideal candidate has deep expertise in drug safety monitoring, workflow management and signal detection, with firm grasp of needs of the life sciences industry and global regulators.

Title: Subject Matter Expert, Offering Management (Drug Safety Monitoring Offerings)

Location: Cambridge, MA (Preferred); Anywhere in the US

Who we are:

We, Watson Health, aspire to improve lives and give hope by delivering innovation to address the world’s most pressing health challenges through data and cognitive insights. Watson Health is supported by the proven innovation of IBM, the dynamic intelligence of Watson, and our collective expertise in and commitment to improving the health industry. The convergence of data and technology is transforming healthcare and life science in every way. New roles are being created that never existed before to meet these demands. In this moment of remarkable change and opportunity, we are looking for talented, passionate individuals who are eager to rise to the challenge.

What will you do:

  • Serve as the domain lead on a dynamic product development and offering management team focused on drug safety. You will provide expert knowledge-based input to Watson Health’s Offering / Product Management teams to support the company’s primary goals of aligning a Watson powered drug safety monitoring product strategy to market needs

  • Support the company’s efforts to address industry requirements related to the Drug Safety domain to build best in class software powered by cognitive technologies

  • Work across Watson Health and IBM to advise cross-discipline teams on development, design, marketing, communications, and sales to deliver the most innovative offerings in pharmacovigilance to our clients

  • Serve as a thought leader in pharmacovigilance through active participation in industry events

  • Collaborate with cross functional teams within Watson Health on regulatory stakeholder engagement such as with the Food and Drug Administration

  • Provide insight into how various life sciences companies and their vendors fulfill their drug safety monitoring responsibilities

You are:

  • Passionate about transforming healthcare and life sciences

  • Excited about working in a fast-paced, dynamic environment with multiple priorities

  • An exceptional verbal and written communicator with a proven track record of building consensus within large organizations and disparate groups of stakeholders

  • Exceptionally organized and comfortable working with offering/product, engineering, and design teams

  • Highly knowledgeable in the subject of drug or patient safety

You have these requirements:

  • 5+ years of pharmacovigilance industry experience

  • 5+ years of successfully working with health regulators during signal process inspections and/or management of any resulting actions or findings from inspections

  • Working experience with signal detection, signal validation, and signal management processes

  • Working experience analyzing case series for the purposes of aggregate safety reporting, signal detection and evaluation, issue management, and labeling changes

You have these highly-preferred experiences:

  • 15+ years of pharmacovigilance industry experience

  • 15+ years of successfully working with health regulators during signal process

  • Advanced degree (Master’s or PhD or MD in mathematics, medicine, drug safety, medical information, epidemiology, biostatistics, outcome measurement, health services utilization highly preferred)

  • Experience in pharmacovigilance across a broad set of stakeholders and therapeutic areas

  • Experience consulting across multiple pharmaceutical companies in the pharmacovigilance domain

  • Understanding of Real World Evidence (RWE) data and its application in intake, reporting and signal detection processes

  • Experience incorporating safety findings into Reference Safety Information (USPI, CDS, IB, etc.)

Required Technical and Professional Expertise

  • 5+ years of pharmacovigilance industry experience

  • 5+ years of successfully working with health regulators during signal process inspections and/or management of any resulting actions or findings from inspections

  • Working experience with signal detection, signal validation, and signal management processes

  • Working experience analyzing case series for the purposes of aggregate safety reporting, signal detection and evaluation, issue management, and labeling changes

Preferred Tech and Prof Experience

  • 15+ years of pharmacovigilance industry experience

  • 15+ years of successfully working with health regulators during signal process

  • Advanced degree (Master’s or PhD or MD in mathematics, medicine, drug safety, medical information, epidemiology, biostatistics, outcome measurement, health services utilization highly preferred)

  • Experience in pharmacovigilance across a broad set of stakeholders and therapeutic areas

  • Experience consulting across multiple pharmaceutical companies in the pharmacovigilance domain

  • Understanding of Real World Evidence (RWE) data and its application in intake, reporting and signal detection processes

  • Experience incorporating safety findings into Reference Safety Information (USPI, CDS, IB, etc.)

EO Statement

IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.