Sushma R
About Sushma R
Sushma R is a Clinical Safety Specialist at Bristol Myers Squibb with extensive experience in drug safety roles across multiple pharmaceutical companies.
Title and Current Role
Sushma R is a Clinical Safety Specialist currently working at Bristol Myers Squibb. In her role, she ensures that individual training records are maintained in line with inspection readiness. Additionally, she participates in audits, inspections, client interactions, and teleconferences as required. Sushma is accountable for proactive workload management within teams and across functions to meet internal and regulatory timelines.
Previous Experience
Sushma R has held various positions in the pharmaceutical industry, including a tenure as Drug Safety Associate II at The Janssen Pharmaceutical Companies of Johnson & Johnson from 2019 to 2020 in Horsham, Pennsylvania. She also worked at Bioclinica in Princeton, New Jersey, in the same role during the same year. Prior to these positions, she served as a Drug Safety Associate at Shire from 2018 to 2019 in Cambridge, Massachusetts, and at IQVIA from 2015 to 2018 in Durham, North Carolina.
Education and Expertise
Sushma R studied at JNTUH College of Engineering Hyderabad, where she earned a Master's degree in Pharmaceutical Sciences between 2011 and 2013. She has extensive experience in MedDRA and WHO-DD coding and SAE narrative writing. Sushma possesses excellent knowledge of all phases of the drug development process along with a thorough understanding of FDA regulations, ICH GCP, global clinical trial regulations, and guidelines.
Regulatory and Submission Knowledge
Sushma R has a comprehensive understanding of IND and NDA submissions, making her a valuable asset in the field of regulatory affairs. She ensures that all necessary documentation is prepared to meet internal and regulatory timelines.
Skills in Project Planning and Management
Sushma R is skilled in project planning and management. She takes team briefs, addresses issues, and updates the team with any new changes. Her role involves coordinating efforts across functions to ensure seamless project execution.