Intellectual Property Senior Consultant- Toxicology

Evalueserve is a global professional services provider offering research, analytics, and data management services. We’re powered by mind+machine – a unique combination of human expertise and best-in-class technologies that use smart algorithms to simplify key tasks. We work with clients across a wide range of industries and business functions, helping them to make better decisions faster; reach new levels of efficiency and effectiveness; and see a tangible impact on their top and bottom line. We are committed to providing equal employment opportunities (EEO) globally, eliminating discrimination, and promoting good relations among employees, regardless of age, disability, ethnicity or origin, sex, gender assignment, gender identity, religion or belief, sexual orientation, and marital or civil partnership status. Evalueserve is an inclusive employer and is proud of its diverse workforce

We are in search of an adaptable, self-driven, and collaborative individual. The ideal candidate should possess the ability to take initiative and work independently, while also understanding the dynamics of a service-oriented consulting firm. Additionally, the candidate should demonstrate a keen interest in actively participating in business development efforts.

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.

Compensation

• To be decided on a case-by-case basis, pegged with the best in the industry