Hyderabad

Experience in preparation/review of PSURs/PBRERs, PADERS, Signal Evaluation Reports, and Risk Management Plans

Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.

Quality Operations supports in batch release preparatory activity, QMS activity and Regulatory compliance check. Novartis

This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials.

First class post-graduate degree (including integrated PG degree) such as M.S. (Pharm) / M.Pharm or Equivalent (with specialization in Pharmacology & Toxicology/Regulatory Toxicology/Biotechnology. NIPER

PhD in Organic Chemistry / Pharmaceutical Chemistry / Process Chemistry / Natural Products /Medicinal Chemistry from a recognized University or equivalent. Research experience in organic synthesis, purification techniques, and spectral characterization will be preferred, NIPER

Hands-on experience in Analytical Method Development, Method Validation, and Routine Analysis. 

Bachelors degree in medical, Mechanical, Electric Life Science or other healthcare related majors. Set up new process for entering new data - Regulatory Information Management System.

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products