Veterinarian, Pharmacovigilance

BoehringerPRD•Duluth, GA

34d

About The Position

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 Veterinarian, Pharmacovigilance ensures compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.) as described in the corporate and BIAH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. Review, Assess and approve product/adverse event complaints for BIAH products manufactured or sold in the US, and submit to appropriate authorities as required. May provide support to Pharmacovigilance (PV) Management in the area of ADE analysis, PV trending and/or signal detection. Ensures regulatory compliance of Pharmaceutical Advertising and Promotional Labeling by reviewing and approving assigned promotional pieces.

Requirements

Veterinary degree (DVM or VMD) from an accredited institution with three (3) years´ of veterinary practice experience or Pharmacovigilance, Pharmacoepidemiology or related field experience.
Thorough knowledge of animal disease processes.
Strong interest and capability in working in a pharmacovigilance program in a call center/post-market surveillance environment.
Ability to communicate effectively both orally and in writing in an interdisciplinary environment.
Appropriate level of understanding of applicable regulations.
Respectful interactions with individuals with diverse views or backgrounds.

Nice To Haves

Previous pharmaceutical industry or drug safety/pharmacovigilance experience preferred.
Basic knowledge of statistics and application of statistical analysis in data mining and trending preferred, experience in pharmaco-epidemiology a plus.

Responsibilities

Reviews and evaluates all complaints for accurate and consistent data, coding and case assessments and submission to applicable regulatory authorities.
Supports the training of 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).
Assists 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.
Assists 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.
Assists in the preparation of information to support 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 as required.
Reviews and approves 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)
May assume additional responsibilities as assigned by supervisor or LPV.
Participates in other tasks and projects as assigned.
Mainly US domestic focus, decisions however do affect global PV assessment. May provide PV support for non-US colleagues/products.