Mansi

About Mansi

I am a well-organized, conscientious and highly energetic person who is dedicated to the quality, completeness, and timeliness of work delivered. I pride myself on being able to work hard and go the extra mile. This has led me to obtain outstanding grades while delivering services for clients and to gaining more responsibilities in my previous employment. Self-disciplined and ambitious, I am constantly looking to improve my standards of excellence by seeking out challenging situations, learning new competencies and skills, and integrating ongoing feedback from clients, managers and peers. Through my numerous experiences, I have time and again proven my remarkable communication and interpersonal skills.• More than 7 years of experience in Pharmacovigilance including medical writing of Safety Evaluation Reports and medical assessment, triage, data entry, data validation and quality check of Individual Case Safety Reports (ICSR) cases. • Experienced in Safety Signal Management process (signal detection, prioritization, validation, evaluation, analysis and assessment).• Responsible for ongoing core signal detection activities for Global Safety Officer review.• Experienced in Medical writing, medical conclusions and company comments for safety reports.• Core member and coordinator of Safety Management Committee (SMC) and Safety Management Team (SMT).• Provide strategic input and review of applicable sections of Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).• Trained in Eudravigilance signal detection activities.• Interacting with appropriate client personal to resolve issues related to the processing of ICSRs in accordance with client’s policies.• Experienced in managing ICSRs of various case types (spontaneous, clinical studies, solicited programs and literature cases)-Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities-Registration of ICSRs into the safety database -Conducting duplicate searches prior to registration and identifying potential duplicates-Managing duplicate cases appropriately-Data entry and case assessment of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SmPC, CCDS, IB etc.),

Experience

1. Associate Director, Patient Safety Scientist

   AstraZeneca

   Feb 2026 — Present

Education

• Maharshi Dayanand University

  Master's degree, Biotechnology

  2010 — 2012