Firoz Momin

Background

About Firoz Momin

Clinical Research Professional with over 13.8 years of experience in Regulatory Medical Writing (6.5 years), Clinical Data Management (3 years), and Medical Affairs domains (4 years and counting). Demonstrated history of working in the medical affairs domain since 2021, with hands on experience in: Authoring sections of Periodic Benefit-Risk Evaluation Reports (PBRERs), addendum to Clinical Overview (ACO), and Clinical Overview (CO), authoring end to end Health-Hazard Assessment (HHA)(drug-only HHA, Biologics, and medical device and combination product [MDCP] HHA), Hazard Analysis for MDCP products, slide decks, medical to medical review, extensive literature search using various databases such as OVID (Medline, Biosis, and Embase), PubMed, MedRxiv, ClinicalTrial.gov.in, EudraCT, Google Scholar, etc as part of Literature Search CoE. Product Maintenance and Defense activities, extending support for product withdrawals, label updates, HA queries, and ad-hoc scientific evidence searches through effective literature search and summary. Drug-Drug Interaction review of selected Pfizer products. Attending Risk Management Committee (RMC) for Signal management, query solving, and medical inputs. Review of Medical Devices Design History Forms (DHFs) such as uFMEA, Hazard Analysis (HA), etc Newsletters for Internal Pfizer stakeholders. MDD calculation & dose recommendation. Drafting of Medical Assessment for Reg21 and slide decks for Medical Evaluation Committee Review. GenAI prompts testing for internal web portals. PowerBI reports for Medical Information Team. Assisting Publications Writer in Scoping, Review, and Data extraction activities for Systematic Literature Reviews (SLRs). Project Management and Process Improvement Assisting Senior Directors with all Medical Affairs activities. A total of 6.5 years of experience in regulatory medical writing (RegMW) with a Pharma MNC, specialized in authoring Clinical Study Reports (CSRs), Protocol & amendments, IB updates, and Patient Safety Narratives. QC review of various documents such as protocols, CSRs, narratives, briefing book, summary bridging document, ToS, IB, modules of RMP, CO, HA Query, summary documents (SCP, SCS, ISS), DSUR LL and DSUR ToS, and other regulatory documents. Explored enormously in medical device CSRs; especially in Ophthalmology therapeutic area. Able to handle multiple projects. Three years of experience in core Clinical Data Management domain, worked from study setup to database lock across various therapeutic areas.