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Sr. Techno-Functional SME - Pharmacovigilance, Data & AI
- Raritan, New Jersey
- pozent corporation
- Full Time
- Federal Government
Army Reserve Certified Registered Nurse Anesthetist (CRNA)
- Raritan, New Jersey
- United States Army
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- Public Health

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Sr. Techno-Functional SME - Pharmacovigilance, Data & AI
- Raritan, New Jersey 08869 United States
- pozent corporation
- Aug 21, 2026
- Full Time
pozent corporation

Government jobs offer stability, competitive benefits, and the chance to make a meaningful impact on your community and country. Whether you’re starting your career or seeking new opportunities, these roles provide pathways for growth, security, and service. Explore positions across a wide range of fields and take the first step toward a rewarding future in public service.
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Job Details
- Full Time
- Aug 21, 2026
Job Description
Position: Sr. Techno-Functional SME-Pharmacovigilance, Data & AI
Location: Raritan, NJ (Hybrid)
Start date: ASAP
Emp Type: Full-Time or C2H

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

Aggregate reporting

Benefit-risk assessment

Risk management planning

Regulatory submissions and compliance

Advise 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

Collaborate with data scientists, engineers, and business teams to operationalize AI solutions.
Techno-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

Experience with cloud and data platforms such as:

Databricks

Snowflake

Microsoft Azure or any Cloud

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.

This role is ideal for a senior leader who can seamlessly connect Pharmacovigilance business processes with Data, Analytics, and AI capabilities to drive innovation and operational excellence across the life sciences ecosystem. Position: Sr. Techno-Functional SME-Pharmacovigilance, Data & AI
Location: Raritan, NJ (Hybrid)
Start date: ASAP
Emp Type: Full-Time or C2H

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

Aggregate reporting

Benefit-risk assessment

Risk management planning

Regulatory submissions and compliance

Advise 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

Collaborate with data scientists, engineers, and business teams to operationalize AI solutions.
Techno-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

Experience with cloud and data platforms such as:

Databricks

Snowflake

Microsoft Azure or any Cloud

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.

This role is ideal for a senior leader who can seamlessly connect Pharmacovigilance business processes with Data, Analytics, and AI capabilities to drive innovation and operational excellence across the life sciences ecosystem.
Apply Now View job
Share this job:
Please mention you found this employment opportunity on the CareersInGovernment.com job board.
pozent corporation

Government jobs offer stability, competitive benefits, and the chance to make a meaningful impact on your community and country.

Whether you’re starting your career or seeking new opportunities, these roles provide pathways for growth, security, and service.

Explore positions across a wide range of fields and take the first step toward a rewarding future in public service.
pozent corporation
- https://careersingovernment.com/
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Sr. Techno-Functional SME - Pharmacovigilance, Data & AI

Army Reserve Certified Registered Nurse Anesthetist (CRNA)

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

pozent corporation

Job Details

Job Description

pozent corporation

pozent corporation

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2 Jobs in Raritan

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

Army Reserve Certified Registered Nurse Anesthetist (CRNA)

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Job Details

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