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Nisha Kumari

Analyst (Toxicology) at Evalueserve || Intas (Biopharma) || NIPER Raebareli

Gurugram

3+ years of work experience

Evalueserve
Mar 20251 yr 3 mosPresent

Gurugram, Haryana, India

Intas Pharmaceuticals
Feb 20241 yr 2 mosMar 2025

• Prepare risk assessments for drug products based on permitted/acceptable daily exposure limits (PDE/ADE) • Prepare and review pre-clinical (toxicology) study proposals, study monitoring plans, and reports • Prepare Investigator’s Brochures (IB), CTD (non-clinical overview, summary, and Module 4). • Prepare and review/update Prescribing Information (PI), Summary of Product Characteristics (SmPC), Patient Information, and MSDS. • Review/update Leaflets and Label Artwork based on comments from regulatory agencies. • Review pre-clinical reports.
Intas Pharmaceuticals
Feb 20231 yr 1 moFeb 2024

APCER Life Sciences
Jun 20222 mosJul 2022

Ahmedabad, Gujarat, India

Case Processing

Education

National Institute of Pharmaceutical Education and Research

M.S. (Pharm), Pharmacology and Toxicology

National Institute of Pharmaceutical Education and Research

20202 yrs2022
Raj Kumar Goel Institute of Technology, Ghaziabad

B.Pharm, Pharmaceutical Sciences

Raj Kumar Goel Institute of Technology, Ghaziabad

20164 yrs2020

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Headline

Analyst (Toxicology) at Evalueserve || Intas (Biopharma) || NIPER Raebareli

Location

Gurugram

Work experience

Analyst at Evalueserve, Mar 2025 - Present · 1 yr 3 mos, Gurugram, Haryana, India

Research Associate at Intas Pharmaceuticals, Feb 2024 - Mar 2025 · 1 yr 2 mos, • Prepare risk assessments for drug products based on permitted/acceptable daily exposure limits (PDE/ADE) • Prepare and review pre-clinical (toxicology) study proposals, study monitoring plans, and reports • Prepare Investigator’s Brochures (IB), CTD (non-clinical overview, summary, and Module 4). • Prepare and review/update Prescribing Information (PI), Summary of Product Characteristics (SmPC), Patient Information, and MSDS. • Review/update Leaflets and Label Artwork based on comments from regulatory agencies. • Review pre-clinical reports.

Trainee Research Associate at Intas Pharmaceuticals, Feb 2023 - Feb 2024 · 1 yr 1 mo

Pharmacovigilance Trainee-Associate at APCER Life Sciences, Jun 2022 - Jul 2022 · 2 mos, Ahmedabad, Gujarat, India, Case Processing

Education

M.S. (Pharm), Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research

B.Pharm, Pharmaceutical Sciences, Raj Kumar Goel Institute of Technology, Ghaziabad

Nisha Kumari - Analyst in Gurugram | Tal