Helan Mathai

Background

About Helan Mathai

Professional Experience •More than 10 years of experience in implementing Good Pharmacovigilance Practice (GVP), risk evaluation & safety management and mitigation plans as per US FDA, ICH-CIOMS guidelines, clinical trial guideline (GCP), SOPs and regulations. • Accountable for answering filing queries, eTMF questions from CRO and clinical study team. • Ability to prepare drug safety or periodic safety update report (PSUR), development safety update report (DSUR) and Individual case safety report (ICSR). • Monitored multiple electronic safety mailboxes to include identifying, tracking, and filing AE information. •2+Years- Experience in using Argus, ARISg, AERS, MedDRA and WHO-Drug Dictionaries for coding adverse events terms, medical terminologies, and drugs • 5+ Years- Monitored clinical study and reviewed Trial Master File (Protocols, eTMF, IB, ICD, CRFs, INDs, and other relevant documents) to ensure accuracy and compliance to ICH/GCP, sponsor requirement and IRB policy Skills Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Strong planning,and organizational skills to enable effective prioritization of workload and workload of team members Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization Comprehensive understanding of the practices, processes, and requirements of clinical monitoring Strong judgment, decision making, escalation, and risk management skills In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.