Boehringer Ingelheim Sr. Manager, Veterinarian Global Pharmacovigilance 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.
Ensure Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EPA, EMA, etc..) as described in the corporate and BIVI PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. Assess and approve product/adverse event complaints for BIVI products manufactured or sold in the US, and submit to appropriate authorities as required. Provide support to Pharmacovigilance (PV) Management in the area of PV trending and signal detection (Benefit/Risk Management). Ensure regulatory compliance of Pharmaceutical Advertising and Promotional Labeling by reviewing and approving assigned promotional pieces
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:
Review and evaluate all complaints for accurate and consistent data, coding and case assessments. Together with Manager, responsible for Complaint Case approval.
Provide training on pharmacovigilance procedures and processes as necessary (pharmacovigilance personnel, investigator meetings, sales staff training sessions, medical science liaison training sessions, SOP meetings and other meetings as needed).
Assist with the evaluation of case data to monitor/identify potential product trends and safety signals. Performs targeted data mining and contributes to safety risk assessments in support of BIAH projects/products as needed (Benefit/Risk Management).
Assist stakeholders with PV reports as requested.
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.
Maintain excellent and up-to-date BIAH product knowledge.
Perform duties as Deputy Pharmacovigilance Manager
Prepare regulatory reports; 3 Day Alerts, 15 Day Alerts, Periodic Reports and provide data for USDA APHIS inquiries and/or CVM follow up case reports in a timely manner
Review and approve Pharmaceutical Advertisement and Promotional labeling consistent with applicable company policies and compliance regulations (Including but not limited to 21 CFR 514.80 & 21 CFR 202.1)
DVM from an accredited institution with minimum of five (5) years previous experience in veterinary practice.
Previous pharmaceutical industry or drug safety/pharmacovigilance experience preferred.
Thorough knowledge of animal disease processes.
Strong interest and capability in managing a pharmacovigilance program in a call center/post-market surveillance environment.
Ability to communicate effectively both orally and in writing in an inter disciplinary environment
Basic knowledge of statistics and application of statistical analysis in data mining and trending preferred, experience in pharmaco-epidemiology a plus.
Appropriate level of understanding of applicable regulations
Respectful interactions with individuals with diverse views or backgrounds
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
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.
Organization: US-Merial, Inc.
Title: Sr. Manager, Veterinarian Global Pharmacovigilance
Location: Americas-United States-GA-Duluth
Other Locations: Americas-United States-MO-Saint Joseph
Requisition ID: 182633