Simrita Singh

Background

About Simrita Singh

As a Drug Safety Associate II at Parexel International, I have honed my expertise in regulatory compliance and safety report submissions. My role involves co-authoring and reviewing clinical trial documents, spearheading signal detection activities, and managing expedited safety reports. These responsibilities have allowed me to enhance compliance and accuracy significantly, ensuring 100% adherence to regulatory standards. My current projects focus on improving safety topic resolution and supporting Risk Management Committee discussions, which have led to notable improvements in safety processes. Previously, as a Pharmacovigilance Scientist at Parexel, I managed Individual Case Safety Reports (ICSRs) and contributed to drafting Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). My educational background includes a Master of Science in Microbial Biotechnology and a Bachelor's in Biotechnology Honors from Panjab University, where I specialized in pharmacovigilance, regulatory affairs, and clinical trials. This foundation has equipped me with a deep understanding of microbial biotechnology and clinical research methodologies. I possess a robust set of technical skills, including adverse event reporting, signal detection, and regulatory compliance. My software proficiency spans Oracle Clinical, Argus Safety, and Veeva Vault, among others. Additionally, I hold an Add-on Certificate & Diploma in Bioinformatics, which has enriched my knowledge in data analysis and computational techniques. My ability to train and mentor team members further underscores my leadership and collaborative skills. What sets me apart is my unwavering attention to detail, strong communication skills, and problem-solving abilities. I am adaptable and thrive in dynamic environments, consistently delivering high-quality results. My commitment to integrity and confidentiality ensures that I maintain the highest standards in all my professional endeavors. I am eager to bring my expertise and passion for drug safety and regulatory affairs to a forward-thinking organization, where I can contribute to impactful projects and drive positive outcomes.