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BriefCase

Ip Senior Consultant-toxicology Job in Evalueserve

Ip Senior Consultant-toxicology

Evalueserve 3 weeks ago
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Job Summary Job description End-to-end project management with proven client-facing and internal communication skills. Assist in defining project scope and objectives, resources allocation ensuring flawless execution of multiple projects. Manage relationships with clients and relevant stakeholders. Prepare comprehensive Common Technical Document (CTD) dossiers in compliance with international regulations and marketing submission requirements. Develop and review reports on Health Based Exposure Limits (HBELs) such as (PDE/ OEL/ ADI) for various chemicals. Conduct scientific literature searches to gather, analyze, and compile relevant scientific data from diverse clinical and non-clinical safety, and efficacy databases. Evaluate the quality, produce data summaries, and draw conclusions for various toxicological endpoints such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive toxicity, developmental toxicity, and toxicokinetics, in accordance with guidelines/ guidance established by OECD, ICH, and EPA. Review and author hazard or safety assessments for various chemical products such as pharmaceuticals, cosmetics, nutraceuticals, agrochemicals, botanicals, and biomedical devices Draft environmental and ecotoxicity assessments pertaining to chemicals, specifically addressing factors like persistence, bioaccumulation, and toxicity. Mandatory Skill Set Required Proficient in drafting and reviewing non-clinical modules of CTD Preparation of HBELs as per regulatory requirements. Demonstrated expertise in writing and submitting hazard or safety documentation in compliance with various regulations such as EU, EPA, ICH, or FDA. Familiar with a range of toxicology, pharmacology, clinical, and regulatory databases, as well as their search strategies, for the purpose of identifying high-quality data. Demonstrates a comprehensive understanding of diverse toxicological studies and their principles in accordance with OECD guidelines. Excellent interpersonal skills and effective written and verbal communication abilities. Proficient in completing tasks within assigned areas of responsibility with accuracy and timeliness. Exhibits attentive and active listening skills. Demonstrates strong teamwork skills and logical reasoning. Displays the ability to identify proactive approaches to contribute towards the firm's goals and mission. Open to challenging existing practices by introducing innovative work methodologies. Education and Experience M.Sc, M. Pharm or Ph.D in Toxicology/Regulatory Toxicology. A minimum of 8-12 years of professional experience in the chemical, consumer product, or pharmaceutical industry. DABT certification preferred.
Qualification :
M.Sc, M. Pharm or Ph.D in Toxicology/Regulatory Toxicology
Experience Required :

8 to 12 Years

Vacancy :

2 - 4 Hires

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