Pallavi Dhillon, PharmD, Ph.D., is working at ClinFomatrix, NJ, USA, and New Delhi, India, and Trans Atlantic Therapeutics, New Jersey, USA, Director and Head of Clinical Operations and Drug Safety, USA, for more than 5 years and managing drug safety program globally, Quality Review of ICSRs, write and review safety narratives, pharmacovigilance Control document, monitoring of the compliance of outsourced pharmacovigilance activities. Lead concepts of quality management and inspection readiness within the study Clinical project monitoring and management to ensure that clinical trial project and process work was conducted to internal and external standards. This included ensuring that all colleagues, both internal as well as preferred CROs and partners, were regulatory inspection ready and staff were compliant with ICH GCP and relevant national and international regulations and guidelines and corporate policies and SOPs. Conducting clinical site feasibility studies as well as clinical site identification starting from Phase-I to Phase IV. Monitoring the clinical sites as per the monitoring plan to ensure that Principal Investigator(s) are conducting the study as per Protocol, ICH-GCP & SOPs. Pallavi Dhillon have experience in neuroscience drug development and safety: schizophrenia, depression, mania, bipolar disorder, pediatric bipolar, pediatric schizophrenia, neuropathic pain, inflammation; osteoarthritis in CNS patients. Pallavi Dhillon also have significant experience in Oncology: Phase 1-3 clinical trials, Solid tumor studies; lung cancers, head and neck, breast, liver, colorectal, prostate, and ovarian; hematologic tumors, leukemia, and myeloma blood disorders. Pallavi Dhillon also led the Cardiovascular: Lipid studies, Women's health: Osteoporosis; migraine, non-interventional studies, Infectious disease: HIV/AIDs; vaccine; upper respiratory tract infections, pediatric sinusitis, Specialty Care/Other Therapy Areas: Inflammation, rheumatology, urology. Pallavi Dhillon completed my doctor of philosophy, master and Bachelor's in pharmacy, at MDU Rohtak, India. Pallavi Dhillon worked at leading pharmaceutical companies; Baxter Healthcare India, Pharmacovigilance Specialist, India, and Pfizer Pharmacovigilance Officer, New Delhi, India, and was responsible for all AEs, SAEs, medication errors, and product complaints. Differentiating between Initial and Follow-up reports using ARGUS Working on database Pfoenix and ARGUS for comparison of Adverse Events and completing follow-up reports. QC of cases, AEM report forms for any kind of errors. Undergo client mentorship as designated by the project manager. I also worked as Clinical Research Associate, at Sir Ganga Ram Hospital, New Delhi, and managed phase 3 protocols, recruitment, patient screening, patient consent forms and follow-up management with Investigator. Maintained source documentation and drug accountability, SAEs reporting, maintained site master file. HIPPA inclusions for IRB/IEC submission. Pallavi Dhillon was a Trainee Clinical Research Associate, at Clinsys CRO, Noida, India and Assisted in the conduction of BA/BE studies. To prepare readiness of the clinical facility and all study/system-related documents for the audit process (QA audit, any regulatory Sponsor audit, etc) at all / times. Pallavi Dhillon completed an internship at Clinsys Clinical Research Organization as, Clinical Research Coordinator, Retention/recruitment Patients in India. Pallavi Dhillon am a member of the Pharmacy Associations of India and a registered pharmacist in India.