Manager/AD, Global Pharmacovigilance
Boehringer Ingelheim
St Joseph, MO, USA
Posted on Sep 18, 2025
Description
This is a multi-level posting. Candidates will be hired in at the level based on education, experience, and business need.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
This role ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc..) as described in the corporate and Boehringer AH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. This role will review, assess, and approve product/adverse event complaints for Boehringer AH Product globally and submit to appropriate authorities as required. The incumbent provides expert guidance to Global Pharmacovigilance (PV) Management around ADE analysis, interpretation of PV trends and/or signal detection.
This role provides expert guidance and functional support to the Global PV Team and leads data quality of complaint handling process to ensure compliance with all competent authorities. This role performs triage and case review of adverse events for Boehringer AH products globally. The incumbent is responsible for and develops technical training and monitors the technical expertise of other personnel in the department.
This role contributes to the knowledge base of the department and acts as a key resource for internal and external colleagues. The position holder is recognized as a Subject Matter Expert in Pharmacovigilance Data/Quality and case review by internal and external colleagues and acts as a resource and trainer for colleagues.
Duties And Responsibilities
Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
This is a multi-level posting. Candidates will be hired in at the level based on education, experience, and business need.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
This role ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc..) as described in the corporate and Boehringer AH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. This role will review, assess, and approve product/adverse event complaints for Boehringer AH Product globally and submit to appropriate authorities as required. The incumbent provides expert guidance to Global Pharmacovigilance (PV) Management around ADE analysis, interpretation of PV trends and/or signal detection.
This role provides expert guidance and functional support to the Global PV Team and leads data quality of complaint handling process to ensure compliance with all competent authorities. This role performs triage and case review of adverse events for Boehringer AH products globally. The incumbent is responsible for and develops technical training and monitors the technical expertise of other personnel in the department.
This role contributes to the knowledge base of the department and acts as a key resource for internal and external colleagues. The position holder is recognized as a Subject Matter Expert in Pharmacovigilance Data/Quality and case review by internal and external colleagues and acts as a resource and trainer for colleagues.
Duties And Responsibilities
- Reviews and evaluates all complaints for accurate and consistent data, coding, case assessments and submission to applicable regulatory authorities
- Leads training on implementation of changes to case processing or data entry
- Is considered a Subject Matter Expert regarding PV case processing and data entry
- Develops and Guides training for pharmacovigilance procedures and processes as necessary
- Responsible for and guides the evaluation of case data
- Performs Data Quality and compliance reviews as assigned for External Partners providing outsourced services for all Boehringer Products globally
- Performs re-training for External Partners as needed
- Independently applies basic scientific principles, performs literature searches, keeps abreast of literature in own field and attends scientific meetings; demonstrates a contemporary level of technical proficiency in field
- Performs all company business in accordance with all regulations and company policies and procedures
- Immediately reports noted/observed violations to management
- Prepares regulatory reports; 3 Day Alerts, 15 Day Alerts, Periodic Reports and provides data for USDA APHIS inquiries and/or CVM follow up case reports in a timely manner as required
- Supports coordination and production of PV related reports and documents including but not limited to: Safety Update Reports (SUR), Product Benefit Risk Reports including Annual Statement, PV statements, Reconciliation reports in compliance with internal procedures
- Maintains compliance with corporate procedures and with global regulatory requirements
- Provides support during audits and inspections as needed
- Manages deviations, Corrective Action Preventive Actions (CAPAs) and other PV compliance issues to resolution
- Provides expert input on the PSMF iteration update compilation, manage the documentation of the iteration and file the updated versions as per internal process
- Manages the collection, review, and approval of Global PV procedures and quality documents (SOPs/Guidelines)
- Participates in the drafting, review and implementation of Global PV SOPs and related documents, and this within an environment of continuous improvement
- Initiates and maintains document and information storage and retrieval functions for Global PV Teams
- Evaluates and acts to ensure document quality
- Resolves issues regarding documentation to be archived
- Determines appropriate distribution for document and procedure updates
- Proactively contributes as an expert to developing and managing the Global PV Systems access curriculum and training program, including targeted maintenance qualification programs and training due to system upgrades or process changes
- Performs all company business in accordance with all regulations and company policies and procedures
- Immediately reports noted/observed violations to management
- Demonstrates high ethical and professional standards with all business contacts to maintain company's excellent reputation in the community
- Manages pre-audit or inspection meetings, trainings, preparations, as appropriate by region
- Provides expert input to local PV responsible in responding to health authority questions or inspection findings in close coordination with Head of PV and Qualified Person for Pharmacovigilance (QPPV)
- Veterinary degree (DVM or VMD) required
- Five (5) Years of experience in a related Pharmacovigilance field with a proven track record of adding value to the organization
- Previous pharmaceutical industry or drug safety/pharmacovigilance experience required
- Fluent in spoken and written English
- Extensive working knowledge with Microsoft Office products and databases
- Must have excellent organizational and time management skills
- Ability to work in a team environment or experience working in a project environment
- Excellent oral and written communication skills are required to work with diverse cultures and multiple departments
- Ability to remain calm under pressure and work to meet strict regulatory timelines
- Excellent Attention to detail, quality focused and strong technical and problem-solving skills
- Ability to manage conflict and provide solutions to balance business need with user friendliness
- Occasionally may need to be flexible with working with team members in different time zones
- Experience working with PV-Works, Trackwise or similar databases
- Experience working within regulated pharmaceutical and/or biological industry environments
- Must possess a strong understanding of basic veterinary practice issues and procedures
- Stakeholder focus - dedicated to meeting the expectations and requirements of internal and external stakeholders
- Ability and a strong desire to know or learn something, interest, curiousness
- Open-minded integrator with demonstrated ability to think outside of the box and challenge the status quo
- Knowledge of Pharmaceutical Life Cycle Process
- Knowledge of Regulatory Requirements & Compliance
- Analytical Thinking
- Managing Conflict
- Leveraging Strategic Relationships
- Negotiation Skills
- Market knowledge
- Planning and Organization
- Quality Orientation/Bus Process Excellence
- Communication
- Problem Solving / Resolution
- Project/Program Management
- Growth talent
- Managing Performance
- Leveraging Strategic Relationships
- Lead & Manage Change
- Set Direction
- Motivation
- Emotional Intelligence
- Business Acumen and Technical Knowledge
- Customer Orientation
- Delivering Results
- External Focus
- Fast and Focused Execution
- Innovation and Change
- Teamwork and Collaboration
- Winning Vision
- Continuous Learning
- Communicate with candor
- Decide and act with speed
- Innovate and drive change
- Deliver to win
- Collaborate with a purpose
- Values Diversity & Inclusion
- Integrity & Trust
- Veterinary degree (DVM or VMD) required
- Three (3) Years veterinary practice experience or Pharmacovigilance, Pharmacoepidemiology or related field experience
- Previous pharmaceutical industry or drug safety/pharmacovigilance experience required
- Fluent in spoken and written English
- Extensive working knowledge with Microsoft Office products
- Must have excellent organizational and time management skills
- Strong oral and written communication skills, including presentation skills, are required
- Ability to distill complex topics and ideas into easily accessible information
- Ability to remain calm under pressure and meet strict regulatory timelines
- Excellent Attention to detail, quality focused and strong technical and problem-solving skills
- Thorough knowledge of animal disease processes
- Strong track record of success in a pharmacovigilance program
- Appropriate level of understanding of applicable regulations
- Respectful interactions with individuals with diverse views or backgrounds, demonstrated cross cultural awareness
- Must possess a strong understanding of basic veterinary practice issues and procedures
- Stakeholder focus - dedicated to meeting the expectations and requirements of internal and external stakeholders
- Ability and a strong desire to know or learn something, interest, curiousness
- Open-minded integrator with demonstrated ability to think outside of the box and challenge the status quo
- Knowledge of Pharmaceutical Life Cycle Process
- Knowledge of Regulatory Requirements & Compliance
- Analytical Thinking
- Managing Conflict
- Leveraging Strategic Relationships
- Negotiation Skills
- Market knowledge
- Planning and Organization
- Quality Orientation/Bus Process Excellence
- Communication
- Problem Solving / Resolution
- Project/Program Management
- Growth talent
- Managing Performance
- Leveraging Strategic Relationships
- Lead & Manage Change
- Set Direction
- Motivation
- Emotional Intelligence
- Business Acumen and Technical Knowledge
- Customer Orientation
- Delivering Results
- External Focus
- Fast and Focused Execution
- Innovation and Change
- Teamwork and Collaboration
- Winning Vision
- Continuous Learning
- Communicate with candor
- Decide and act with speed
- Innovate and drive change
- Deliver to win
- Collaborate with a purpose
- Values Diversity & Inclusion
- Integrity & Trust
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
