*This is a remote position open to candidates located in North America or Europe.*
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D )edication, (E )njoyment, (C )ourage, (H )onesty, (R )elationships and (A )mbition are at the heart of our everyday operations and the way we do business.
Dechra is a global business involved in the development and marketing of veterinary products for dogs, cats, horses and food producing animals. Global Safety at Dechra provides safety expertise for early-stage drug development programs through to marketed products.
Role Responsibility
- Serves as the Safety Technical Lead in Project Teams to define and implement safety strategy.
- Has knowledge of regulatory requirements for safety and toxicology testing for veterinary product development and serves as a resource for this information, ensuring that appropriate elements of safety and toxicity are addressed in data collected to support regulatory submissions.
- With Safety support directs and delivers the design, execution, interpretation, and reporting of safety studies.
- Responsible for the preparation of animal and human health risk assessments using where appropriate established requirements and the generation of toxicological data required to establish MOE, ADI, POD, and MRL values.
- Manages both internal and external resources for the execution of safety strategies.
- Acts as Study Monitor and directs the design and scope of protocols to evaluate product safety in target and non-target species and interprets safety study data to ensure appropriate reflection of findings in study reports.
- Responsible for presentations or discussions with VMD, EMA, FDA and other relevant regulatory agencies on issues related to safety; prepares data reviews or position papers to resolve regulatory issues pertaining to drug safety.
- Responsible for the preparation of drug submissions for Veterinary Medicinal Products / New Animal Drugs.
- May aid in assessment of out of specification batches, safety assessments, E&L QRA evaluation, OELs, SDS preparation.
- Publishes research in peer reviewed publications, and presents research at internal and external scientific venues, as appropriate.
The Ideal Candidate
- PhD in scientific field with a minimum of 3 years relevant industry experience or a Masters Degree with a minimum of 7 years relevant experience.
- Advanced knowledge of toxicology & DMPK.
- Experience with regulatory safety requirements and risk assessment strategies in Animal Health.
- Knowledge of Good Laboratory Practices (GLP).
- Experience managing project budgets and timelines.
- Maintenance of professional certification(s) through training and continuing education.
- GLP study director experience.
- Board certification in toxicology (DABT, ERT).
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
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