Nisha Singh

About Nisha Singh

I have done master\'s degree in pharmacology. I am a passionate individual with excellent motivation and leadership abilities, eager to acquire new skills and techniques. An ability to work independently and in a team, a hard-working personality, and an optimistic outlook helped me in my career. My job skills are: Well versed with Pharmacovigilance concepts (MedDRA coding and WHO-Drug Dictionary coding) and Reporting guidelines (FDA, ICH, EMEA, and other international guidelines). Creating individual case safety reports from the literature articles. Checking validity of cases Identifying suspect drugs and adverse events and the causal relationship Creating concise summaries as per the SOPs and regulatory requirements along with avoiding plagiarism. Knowledge of Case Receipt, Case Triage, Case Narrative writing, performing Labelling/Listedness and Causality determination. Well trained and experienced in identifying and coding events via MedDRA Seeking active feedback and communicating with the Quality reviewers to deliver quality cases Working under strict timelines and delivering cases before the deadlines on daily basis. Maintain communication with Physicians in order to complete the cases as per regulatory requirements. Processing of special situation cases as per SOPs and regulatory guidelines. Basic understanding of Aggregate Reports (PSUR, PBRER, DSUR ), sources of reporting and other terminologies used in ICSRs. Computer proficiency: MS Office (Word, Excel, PowerPoint), End note, Graph Pad Prism, ImageJ. Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements for clinical research and Pharmacovigilance.

Experience

1. Senior Process Associate

   Tata Consultancy Services

   Feb 2026 — Present · Indore, IN

Education

• Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak

  Bachelor of Pharmacy - BPharm, Pharmacy

• Punjab Technical University

  M. Pharmacy, Pharmacology