US_SR AD, GPV Surveillance & Epidemiology

Description

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.

The Senior Associate Director, GPV Surveillance & Epidemiology leads the strategic design, implementation, and continuous advancement of a globally compliant and forward-looking Product Surveillance & Risk Management (PSRM) program within Global Pharmacovigilance (GPV). The incumbent translates evolving and complex regulatory authority requirements into actionable, innovative surveillance strategies that ensure patient safety and regulatory excellence.

The SR AD, GPV Surveillance & Epidemiology serves as the enterprise-wide subject matter expert and primary point of contact for all post-marketing product safety matters. The position holder provides timely, transparent, and high-impact communication to senior leadership, including GPV Leadership, QPPV, GIET/ExCOM, and the Global Safety Committee. This role drives the evolution of the Pharmacoepidemiology function, ensuring the program remains adaptive to the dynamic global regulatory landscape.

The SR AD, GPV Surveillance & Epidemiology leads cross-functional collaboration to deliver high-quality safety data analysis, interpretation, and reporting, while ensuring the provision of critical PV insights (e.g., RPIs) to internal and external stakeholders.

Duties & Responsibilities

• Ensures functional excellence of the team through hiring, development, mentoring and retention of key talent.
• Manages all aspects of team performance, including setting priorities, defining core job expectations, and aligning competencies with GPV and Boehringer AH business goals.
• Coaches and mentors direct reports, ensuring succession planning and active development plans are in place.
• Serves as a strategic liaison with internal and external stakeholders, including Clinical, Commercial Operations, Legal, LPVs, RA, GCB, GSM, and Quality.
• Represents the PV group in meetings with corporate partners, trade associations, and regulatory authorities to proactively ensure PSRM relevant topics are proactively raised and addressed.
• Ensures team training and qualifications are maintained per regulatory requirements and SOPs.
• Ensures the quality, consistency and regulatory compliance of the signal management program.
• Fosters innovation for the signal management program to adapt to a dynamic regulatory landscape.
• Leads the daily operations of the GPV Product Surveillance & Risk Management program, ensuring alignment with corporate procedures and regulatory expectations.
• Executes the real-world data/pharmacoepidemiology strategy focusing on priority projects
• Maximizes use of existing signal management tools and liaise with the PV Systems teams to ensure updates or enhancements as needed.
• Ensures the results of signal management activities are adequately reported to regulatory authorities in compliance with applicable regulatory requirements worldwide.
• Leads the drafting, review, and implementation of departmental SOPs and related documents in a culture of continuous improvement.
• Ensures audit/inspection readiness and represents Boehringer Ingelheim in audits and inspections on relevant topics.
• Leads/supports PV preparation during audits and inspections.
• Actively contributes to signal management activities, including targeted data mining, safety risk assessments and risk minimization measures for Boehringer Animal Health products and projects.
• Communicates and defends strategic scientific responses clearly and effectively, both orally and in writing.
• Critically evaluate questions being asked to ensure strategic approach is taken resulting in appropriate and scientifically sound responses.
• Instills strategic approach to data analysis and reporting in the team.
• Ensure data integrity and uphold the highest ethical standards in all pharmacovigilance activities.
• Independently applies basic scientific principles, performs literature searches, keeps abreast of relevant literature and attends relevant scientific meetings.
• Proactively contributes to the knowledge base of the department and acts as a key resource for colleagues.
• Works with Quality Teams to investigate any relevant drug safety and/or Quality signals and to initiate any relevant CAPAs.
• Escalates PV issues to GPV management and QPPV.  Represents the PSRM team in the Global Safety Committee meetings as requested.
• Performs all company business in accordance with all regulations and company policies and procedures.
• Oversees team-level CAPA and deviation management.
• Immediately reports noted/observed deviations to management.
• Demonstrates high ethical and professional standards with all business contacts to maintain company's excellent reputation in the community.
• Completes other tasks and projects as assigned by supervisor.

Requirements

• Veterinary Degree (DVM/VMD) required; MSc, MPH or MBA preferred.
• Seven (7) years Veterinary practice experience required including five (5) years within a Pharmacovigilance or regulatory/ compliance Animal Health industry environment.
• Fluent in spoken and written English.
• Expertise in Pharmacovigilance & Regulatory Compliance: Deep understanding of Animal Health regulatory and pharmacovigilance laws, guidelines, and compliance systems.
• Veterinary Practice Knowledge: Solid grasp of veterinary procedures and issues relevant to pharmacovigilance.
• Statistical & Analytical Proficiency: High-level knowledge of statistics, data mining, signal detection, and root cause analysis.
• Technical Systems & Databases: Proficiency with electronic databases, compliance systems, and high computer literacy.
• Communication & Negotiation: Exceptional written and verbal English skills, with strong interpersonal, negotiation, and problem-solving abilities.
• Regulatory Agency Engagement: Proven experience working with and influencing global regulatory authorities on PV topics.
• Industry Awareness: Understanding of competitor activities and ability to develop scientific arguments to support product safety.
• Cross-functional Collaboration: Ability to build trust, influence across disciplines, and work effectively in a matrixed, global environment.
• Strategic Execution: Capable of initiating and implementing systems and strategies to meet tight timelines and quality standards.
• Self-driven Leadership: Demonstrated initiative, decision-making confidence, and persistence in managing multiple projects.

Eligibility Requirements:

• 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.

GI_US925 

Desired Skills, Experience and Abilities