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IdentityI have a total of 5 years and 11 months of experience in Pharmacovigilance as medical writer. I have summarized my overall experience in below points for quick look.
· I have experienced in pharmacovigilance aggregate reports writing, which include authoring and reviewing all section of the reports and expertise in writing safety section of the report, an approximately worked on PBRER (n=190), PSUR (n=150), DSUR (n=40) AR (n=35) and assisting in ad hoc request/regulatory responses within timely manner with 100% compliance.
· Responsible for preparation of Risk Management Plans (RMPs) and updates to RMPs (n=10), as primary author and related activities (including collection of data, handling requests received from CT and regulatory affairs department, preparation of risk minimisation measures and TFLs) within timely manner
· Preparation signal evaluation reports (n=15), following PRAC recommendation and signal evaluation cycle for different medicinal products based safety database output and supplement by literature and presentation of relevant significant medical evaluation data in periodic reports.
· I have an experienced in clinical trials for source document verification, performs query resolution in a timely manner. Perform specific protocol procedures such as interviewing subjects, taking vital signs, sample labeling and dispatching, study drug accountability, filling of eCRF and paper CRF for principle investigator review. Responsible for maintaining patient file, site master file, CRF, questionnaire entries, sampling and centrifugation and other documents.
· Depth knowledge of ICH and GVP guidelines
Further, I have enclosed for my resume for your review, my resume indicates a strong foothold for higher challenges. Throughout my academic background and professional experiences, I have consistently driven myself to meet challenges and achieve goals.
