About Nikita Sanap
Nikita Sanap is a dedicated and knowledgeable Drug Safety Associate with a strong foundation in pharmacovigilance, case processing, and global regulatory compliance. She holds a Bachelor's degree in Pharmacy from Dr. Babasaheb Ambedkar Technological University, where she built a solid academic background in pharmaceutical sciences.
- Nikita gained valuable hands-on experience through a one-month internship in Quality Control, which provided her with practical exposure to industrial pharmaceutical processes and quality assurance practices.
- In her current role, she is responsible for the end-to-end management of Individual Case Safety Reports (ICSRs) and plays a critical role in the preparation of aggregate safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- She actively contributes to signal detection and evaluation processes and works collaboratively with cross-functional teams to support comprehensive benefit-risk assessments across the product lifecycle.
- Her proficiency in industry-standard drug safety databases and Quality Management Systems (QMS) enables her to maintain high standards of accuracy, efficiency, and regulatory readiness.
- Nikita is well-versed in global pharmacovigilance regulations, including ICH E2E guidelines, GVP Modules, and FDA/EMA reporting requirements.
- She is also committed to continuous professional development, regularly participating in training programs and staying current with evolving regulatory standards. She is widely recognized for her precision, timely execution, and deep understanding of pharmacovigilance best practices.
