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 a number of 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 AD Global PV Data Analysis supports the Global PV processes to ensure compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EPA, EMA, CFIA etc..) as described in the corporate and BIV PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. In particular, this position is responsible for:     

1) Performing analysis of Data sets as requested

2) Establishing and maintaining ongoing safety surveillance program

3) Supporting Global PV in the analysis and reporting of safety data

4) Providing Pharmacovigilance Information (RPI) as requested

5) Supporting internal audits and regulatory agency inspections

Duties & Responsibilities

Together with Head of PV Operations, establish and maintain scientifically valid ongoing safety surveillance and signal detection programs for marketed products: 

• Actively participate in or lead safety surveillance and signal detection programs for Animal Health products and ensure they are in compliance with current agency expectations 
• Support global and local PV Teams as needed
• Work with Quality Teams to investigate any relevant drug safety and/or quality signals and to initiate any relevant CAPAs
• Proposes, evaluates and implements new tools and methodologies in an environment of continuous improvement
• Maximize use of existing signal detection tools (e.g.: Qlikview)and ensure updates or enhancements as needed. -Form strategic alliances with key internal stakeholders as needed (e.g.: PV, RA, GSM, QA) 

Actively Participate in benefit-risk management of BIAH products:

• Prepares PV documents including but not limited to:
     - Aggregate Safety Data Reports
     - Product Benefit Risk Evaluation Reports
     - PV statements
     - Requests for PV Information (RPI)
• Apply expertise and perform targeted data mining and product benefit-risk assessments in support of BIAH projects/products as needed.
• Provide information, medical assessments and/or trend reports as requested
• As needed, review and evaluate complaints for accurate and consistent data, coding and case assessments. Together with AD PV and PV Veterinarians, responsible for Complaint Case approval and submitting cases to relevant regulatory agencies in a timely manner.

Maintains compliance with corporate procedures and with global regulatory requirements.

• Provides support during audits and authority inspections as needed.

Maintains proper records in accordance with relevant Standard Operating Procedures (SOPs) and policies.

• Participates in drafting and ensures review of department SOPs and related documents, within an environment of continuous improvement.
• Completes other tasks as assigned.
• Proactively assists the team to meet global PV mission:
• Designs and develops solutions to meet business needs and maintain regulatory requirements
• Prepares and delivers presentations for global and regional team meetings as needed               
• Supports global PV activities to meet deadlines and mission of the department                               
• Ensures ongoing development of expertise in PV systems (e.g.: PVWorks, Qlikview).               
• Effectively communicates and defends own work, orally and in writing                                                     
• Reports and treats data with a high level of integrity and ethics.                               
• Independently applies basic scientific principles, performs literature searches, keeps abreast of relevant literature and attends relevant scientific meetings

Requirements

• DVM with a minimum of 2 years experience in Veterinary Practice AND a minimum of 2 years experience in Pharmacovigilance or related field.
• In lieu of a DVM with a minimum of 2 years experience in Veterinary Practice, will accept a Master's Degree (Pharmacoepidemiology, Biology, Data Science, or related field focus preferred), and a minimum of 5 years experience in Pharmacovigilance or related field.

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

Additional Desired Skills, Experience and Abilities

Additional skills:

• Knowledge of statistics and application of statistical analysis in data mining and signal detection required
• Experience with compliance related environment and databases required, high level of computer literacy
• Effective communicator with excellent negotiation and interpersonal skills coupled with strong analytical and creative problem solving skills.
• Ability to form productive working relationships at all levels across disciplines and nationalities.
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Self-motivated decision maker with a high degree of initiative, commitment and persistence.
• Must exhibit good judgement, excellent project management and priority-setting skills.
• Skillful, effective contact and representation of BIAH with relevant global regulatory agencies regarding PV topics and issues.
• Ability to conduct root cause analysis in solving challenges/issues/problems and implement continuous process improvement when necessary.
• Knowledge of Standard Operating Procedures (SOPs)/Guidelines and other applicable local and international regulations governing Animal Health.
• Strong team player who is collaborative with the mission of BIAH