Sr. Techno-Functional SME � Pharmacovigilance, Data & AI

About the role

We are seeking a highly experienced Senior Techno-Functional Subject Matter Expert (SME) with deep expertise in Pharmacovigilance (PV), Drug Safety, and Risk Management, combined with strong knowledge of Data, Analytics, Artificial Intelligence, and modern digital technologies. This role will bridge business and technology teams, driving transformation initiatives across pharmacovigilance operations, regulatory compliance, data platforms, advanced analytics, and AI-enabled solutions. The ideal candidate will possess a unique blend of domain expertise, business process knowledge, data strategy, and technical leadership to help design and implement next-generation PV solutions for global life sciences organizations.

Key Responsibilities

• Pharmacovigilance Leadership

• Serve as the SME for end-to-end Pharmacovigilance processes, including:
• Individual Case Safety Report (ICSR) management
• Case processing and medical review
• Signal detection and management
• Agregate reporting
• Benefit-risk assessment
• Risk management planning
• Regulatory submissions and compliance
• Advising stakeholders on global regulatory requirements and industry best practices
• Support PV operating model design, process optimization, and digital transformation initiatives.

• Data & AI Strategy

• Define and implement data-driven solutions for pharmacovigilance operations.
• Identify opportunities to leverage AI, Machine Learning, Generative AI, and automation across PV workflows.
• Lead use-case development for:
• Case intake automation
• Literature surveillance
• Signal detection and prioritization
• Regulatory intelligence
• Medical content summarization
• Knowledge management and decision support

• Techon-functional Consulting

• Translate business requirements into scalable technology solutions.
• Lead requirements gathering, solution design, vendor evaluations, and implementation planning.
• Provide expertise on safety platforms, data architecture, and integration strategies.
• Act as a trusted advisor to business leaders, product owners, and technology teams.

• Stakeholder Engagement

• Engage with business, clinical, regulatory, safety, and technology stakeholders.
• Conduct workshops, solution reviews, and executive presentations.
• Drive alignment between business objectives and technology investments.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Computer Science, Information Systems, or related field.

• 12+ years of experience in Pharmacovigilance, Drug Safety, or Life Sciences consulting.

• Deep understanding of global pharmacovigilance regulations and safety processes.

• Strong experience working with PV systems and safety platforms.

• Demonstrated experience leading business transformation and technology initiatives.

• Strong understanding of data management, analytics, and AI technologies.

• Experience translating complex business challenges into technology solutions.

• Excellent communication, stakeholder management, and leadership skills.

Preferred Qualifications

• Advanced degree (MS, PharmD, PhD, MBA, or equivalent).

• Experience with leading safety platforms such as: ArisGlobal, LifeSphere Safety, Veeva Vault Safety.

• Familiarity with cloud and data platforms such as: Databricks, Snowflake, Microsoft Azure, AWS.

• Familiarity with Generative AI technologies, LLMs, NLP, and AI governance.

• Experience supporting global pharmaceutical or biotechnology organizations.

Desired Competencies

• Strategic thinking and business acumen.

• Pharmacovigilance process expertise.

• Data and AI solution leadership.

• Enterprise architecture awareness.

• Regulatory compliance mindset.

• Executive communication skills.

• Cross-functional leadership.

• Client-facing consulting experience.

Success Measures

• Delivery of measurable improvements in PV efficiency and compliance.

• Successful implementation of AI and data-driven initiatives.

• Improved business adoption of digital solutions.

• Strong stakeholder satisfaction and executive engagement.

• Establishment of scalable and compliant PV technology frameworks.