Job Information
Boehringer Ingelheim Associate Director, Global Pharmacovigilance Data Analysis in Saint Joseph, Missouri
Description
The AD Global PV Data Analysis supports the Global Pharmacovigilance (PV) team to ensure compliance with all regulations and laws worldwide on Pharmacovigilance (including but not limited to FDA 21 CFR, USDA 9 CFR, and current European regulations). This position is responsible for:
Performing analysis of data sets as on adverse events for safety and efficacy purposes of our veterinary products.
Establishing and maintaining ongoing safety surveillance program to continuous monitor the Risk/Benefit balance of our veterinary products.
Supporting Global PV in the analysis and reporting of AE data internally as to the Health authorities.
Providing Pharmacovigilance Information (RPI) as requested to other departments within the company.
Supporting internal audits and regulatory agency inspections.
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
Together with Head of PV Operations, establish and maintain scientifically valid ongoing safety surveillance and signal detection programs for marketed veterinary products:
Actively participate in or lead safety surveillance and signal detection programs for Animal Health products and ensure they are in compliance with current regulations and laws.
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.
Propose, evaluate and implement new tools and methodologies in an environment of continuous improvement.
Maximize use of existing signal detection tools and ensure updates or enhancements as needed.
Form strategic alliances with key internal stakeholders as needed (e.g.: Pharmacovigilance, Regulatory Affairs, Global Strategic Marketing, Quality Assurance and IT)
Actively Participate in benefit-risk management of BIAH products:
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 regulations and laws.
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 review of department SOPs and related documents.
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).
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
Education & knowledge
Master’s degree in health care sciences from an accredited institution. Preferably a DVM from an accredited institution with a minimum of two (2) years of experience in Veterinary Practice and preferably a minimum of two (2) years of experience in Pharmacovigilance or related field.
Alternatively a Master´s Degree preferably in Pharmacoepidemiology, Biology, Data Science, or related field focus, and a minimum of five (5) years of experience in Pharmacovigilance or related field.
Knowledge of Regulatory/Pharmacovigilance laws and guidelines
Knowledge of statistics and able to apply statistical methods, familiar with data mining and signal detection
Experience working in a GXP/compliance driven environment subject to health authority inspections (FDA, USDA, EMA etc...).
Ability to conduct root cause analysis, find solutions and implement changes to solve issues.
Interpersonal and Communication skills
Effective communicator with excellent negotiation and interpersonal skills.
Self-motivated decision maker with a high degree of initiative and commitment
Ability to form productive working relationships at all levels across disciplines and nationalities as well within the company as outside the company like industry organizations and health authorities.
Ability to remain calm under pressure and able to meet stringent timelines and quality demands. Good in priority setting
Computer system skills
- High level of computer literacy and able to work with different computer systems.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.