Rajinder Kaur

Background

About Rajinder Kaur

Medical Writer with 4.5 years of experience in Clinical/Pharmacovigilance and Regulatory document writing domain. Skilled in writing as well as reviewing the regulatory documents and well versed with the ICH GCP guidelines, U.S. Food and Drug Administration (FDA) guidelines, GVP modules, MedDRA, and labeling documents. Professional Experience: Expertise in authoring various regulatory documents, including SER, PBRER/PSUR, PADER, ACO, IPSR, ANVISA, HHE, Adhoc report. Also contributed in preparation of CSR, RMP, DSUR. Expertise in handling products in therapeutic area of immunology, infectious diseases, oncology, urology and nephrology. Experienced in performing literature triage, medical assessment, and data entry of literature abstracts and writing patient narratives. Proficient in MS Office (Word, Excel, Powerpoint), MedDRA coding, Micromedex, and possess expert knowledge of drug safety database (Argus). Hands-on experience of Medical Writing, Clinical Data Management, Pharmacovigilance, and Regulatory affairs.