Divya Bakshi
Clinical Pharmacist @Spandana Hospitals
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WORK HISTORY
Clinical Pharmacist @Spandana Hospitals
Bengaluru, IN
Successfully completed short term internship program in psychiatric department. Coordinating and preparing document packages for regulatory submissions. Coordinating responses to regulatory agencies regarding product information or issues.• Provide strategic advice to management regarding regulatory issues. Conducting risk assessments of non-compliant situations to determine the best course of action. Monitor legislation relevant to the company and ensure that changes are implemented.
EDUCATION
Sri Chaitanya College of Education
Intermediate, Biology/zoology/chemistry
Rajiv Gandhi University of Health Sciences
Doctor of Pharmacy - PharmD, Clinical Pharmacy, Pharmacology, Drug Therapy Management, Pharmacy Law, Pharmacokinetics
Vijetha high school
Ssc, High School
ABOUT DIVYA BAKSHI
Detail-oriented PharmD graduate with a strong foundation in pharmacology, drug development and clinical research. Analyse and evaluate new and existing pharmaceutical products to ensure they meet all regulatory requirements. Overseeing the preparation, submission and management of medicinal product registration applications to health authorities. Improve processes and policies in support of organizational goals. Ensuring compliance with protocols, standard operating procedures and Good Clinical Practice guidelines. Analyse and conduct regular site visits to monitor trial activities and data collection. Review and analyze clinical trial data for accuracy and completeness. Monitor and collaborate with other departments to develop procedures and ensure compliance with regulations. Monitor and communicate changes in regulatory legislation and guidelines to the relevant departments within the company.
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