Boehringer Ingelheim Specialist, PV Systems & Data Analysis in DULUTH, Georgia
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
The Specialist, Pharmacovigilance and Data Analysis is responsible for
Developing and maintainingreports for the PV/VeTS department
System Administration of the PVWorks and PV Analyzer databases
Maintaining product performanceby trending of adverse events and product quality complaints from themarketplace
Supporting management duringFDA/APHIS/EU and other 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.
Responsible for the research,development, validation and training of reports (crystal and SQL) asrequested by PV Management and in the agreed upon timeline. Thisalso includes producing accurate technical documentation of allprojects asks (specifications, testing documentation, etc...). Update andmaintain existing crystal reports for business needs and evolvingrequirements from regulatory authorities and audits. Runs Monthlyreports for internal BI customers (RA, PV, VeTS, QA,Global PV, Sales andMarketing)
Responsible for systemadministration of PV Analyzer and supports Manager with SystemAdministration of the PV Works environments (development, validation,production and training). Must demonstrate knowledge regarding companyprocesses to ensure entries and/or activities do not interfere with othersystem interfaces and processes. Provides technical assistance to BIAH PVWorks Users regarding processes supported by the PV Works Database andworkflows.
Designs and implements complexdata extracts to support safety signal detection and product trendingprocesses.
Supports the compilation of themonthly and quarterly Pharmacovigilance Trend Analysis Group documentationand reports.
Responsible for maintenance ofthe Technical Services phone system used for all incoming complaints.Research, develop and run Metrics reports to meet VeTS call center needs.Responsible for coordinating office equipment maintenance and replacement.
Maintains compliance withcorporate procedures and with global regulatory requirements. Providessupport during audits and authority inspections as needed. Maintainsproper records in accordance with relevant SOPs and policies. Participatesin drafting and ensure review of department SOPs and related documents,and this within an environment of continuous improvement. Completes othertasks as assigned.
Bachelor’s degree from anaccredited institution in Business, IT or Science.
Project management experiencerequired
Experience developing andmaintaining Crystal Reports required.
Excellent computer skills withexperience in electronic document management systems and -Microsoft Office
Experience with SQL Softwaretools, JMP or equivalent statistical software tools preferred
Must have excellentorganization and time management skills.
Strong communication skills arerequired in order to work with diverse cultures and multiple departments.
Demonstrated ability to work ina team environment or experience working on project teams.
Ability to manage conflict andprovide solutions to balance business needs with user friendliness.
Animal Health or relatedindustry and/or regulatory experience a plus
Experience working in aGMP/compliance environment subject to authority inspections (FDA, USDA,EMA etc.).
Ability to remain calm underpressure and work to meet strict regulatory and customer driven timelines.
Desired Skills,Experience and Abilities:
Experience working withInternational team members in different time zones
Computer skills includingvalidated databases and SAP preferred
Must be legally authorized towork in the United States without restriction
Must be willing to take a drugtest and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Title: Specialist, PV Systems & Data Analysis
Location: Americas-United States-GA-Duluth
Other Locations: Americas-United States-MO-Saint Joseph
Requisition ID: 185133