Pharmacologist/Toxicologist, Nonclinical Operations and Risk Assessment
已发布 2 几个月前
1000 Mylan Inc.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the role will make an impact:Key responsibilities for this role include:
Perform toxicological risk assessments for various health-based exposure limits (HBELs), such as ADEs, PDEs, ADIs, OELs, etc.
Designing, planning and overseeing the conduction of pharmacology, safety pharmacology and toxicology studies.
Perform environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments.
Assess and resolve impurity, degradant and device-related qualification issues including the assessment of extractables and leachables and ICH M7-compliant genotoxicity evaluations.
Assisting in the selection and approval of contract testing facilities used for GLP and non-GLP studies, ensuring data quality and integrity from monitored preclinical sites
Evaluate available approved prescribing information from multiple global regions for the determination of human and veterinary dosing parameters (lowest therapeutic dose and maximum daily dose).
Comprehension of relevant Viatris Standard Operating Procedures (SOPs) and compliance with Laboratory SOPs and other relevant policies.
Author and review research reports, protocols, guidelines and SOPs for the department.
Provide support in the research and construction of regulatory study documents, technical scientific analyses and positional papers (i.e., IND/NDA documents, Applications for Marketing Authorizations, etc.).
Represent the department and Viatris in meetings with global regulatory health authorities and attending internal meetings.
The minimum qualifications for this role are:
Candidates must possess an earned doctoral degree in Toxicology, Pharmacology or related field, an earned master’s degree in an appropriate field with at least 7 years of full-time professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology/pharmacology, or must possess an earned bachelor’s degree in an appropriate field and have at least 10 years professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology/pharmacology.
Must possess knowledge of the biological impact of drug product materials (APIs, excipients, impurities, etc.) in the human body. Knowledge of applicable world health authorities’ regulations, standards and guidelines covering drug development is essential. The knowledge and application of GLP and ISO regulations is required.
Must possess effective oral and written communication, organizational and computer skills. Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner.
Position functions semi-autonomously. Position may directly supervise employees. Must carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Must have expertise and experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in determination of health-based exposure limits.
None required with doctoral degree in Toxicology/Pharmacology. Toxicological certification/registration preferred for educational degrees in unrelated biomedical fields.
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements. Periodic travel is required.
Normal office situation
Proficiency in speaking, comprehending, reading and writing English is required
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $77,000-$148,000.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.