Henu Runthala Email & Phone Number

Dedicated professional with the ability to work well with minimal supervision, with more than 5 years of experience in pharmacovigilance activities, drug safety and training internal teams in organizations. Fluent in English with a CLB level 9. Skilled in Research, Teamwork, Leadership and Microsoft Office. A professional with a Master's degree focused in Microbial Biotechnology from Panjab University, India.Proficient in wide variety of pharmacovigilance activities, task management for clients from USA and Europe. Hands on experience of safety databases like Aris G, Medidata, Enterprise Resource Planning systems and other proprietary databases. Working knowledge of international drug safety regulations, including ICH & FDA guidelines, Health Canada guidelines, CIOMS, New EU PV legislation, and awareness of global regulatory reporting obligations. Expertise in management of Individual Case Safety Reports (ICSRs), including registration/initiation of ICSRs in safety database such as ARIS G. Proficient in triage, data entry, writing case summaries, assessing expectedness and causality of adverse events against drug labels. Experienced periodic batch report E2b submissions to health authorities, literature search and review via PubMed. Experienced in MedDRA activities like Medidata coder, MedDRA QC, coding and mapping. Developed excellent knowledge of key concepts underpinning many of the major fields of biological science, especially microbiology, bio-analytical engineering and pharmaceutical sciences. Handled cases for products in therapeutic areas of Oncology, Infections and Infestations, Dermatology, Cardiovascular, Rheumatology, Immunology/Autoimmune Diseases, Metabolic disorders, Hematology, Virology, Psychiatric and CNS Disorders.