Tirumalasetti S.

A pharmacist with over 3 1/2 of research and clinical application experience. I am trained and licensed to provide expertise in pharmacy, pharmaceutical sciences, pharmacovigilance, pharmacology, clinical outcomes, biology, biochemistry, and genetics. I am detail oriented, adaptable, dependable and most importantly passionate about patient care and the profession of pharmacy. I am also technologically savvy, fluent in PC applications and have the ability to utilize professional clinical tools and top databases (PubMed, Clinical Pharmacology, Natural Medicines, etc.). Invested in carrying out research and in-depth analysis to provide evidence and insights that feeds healthcare decisions, pharma business output and regulatory decisions. Particularly skilled in secondary research on medical literature databases, clinical trial research (Analyzing clinical trials from journals, meeting abstracts, presentations, clinicaltrials.gov and providing valuable information to bio-pharmaceutical companies.), systematic literature reviews, medical writing, pharmacovigilance reports and project management. Expert in tracking regulatory filings and analyze the regulatory information using data sources like SEC files, annual reports, FDA, EMEA & other regulatory websites, abstracts, journals, conferences & events. Performed all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved.  Performed reconciliation of the clinical database against safety data, laboratory data, ECG, PK and other third-party data as appropriate  Reviewed clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data  User Acceptance Testing (UAT)  Participated in Internal Core team and Client meetings and supports the Lead Data Manager with risk management on allocated projects. . I pay adequate attention to all my projects so deliverables are developed excellently and completed in a timely manner thanks to my years of research, medical writing and project management. I am very efficient, organized and result oriented. Feel free to contact me if you require my services. I look forward to working with you.