Firoz Momin

About Firoz Momin

Certified Clinical Research (CCR) Professional with over 14 years of experience in Regulatory Medical Writing (6.5 years), Clinical Data Management (3 years), and Medical Affairs domains (4.5 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 M&D 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, & 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.

Experience

1. Medical Manager (Manager) - Global Medical Affairs

   화이자

   Mar 2021 — Present · Mumbai, IN

   Demonstrated history of working in the medical affairs domain, with hands on experience in authoring, peer review, and QC reviews of: Efficacy/Effectiveness Sections of Periodic Benefit-Risk Evaluation Reports (PBRERs), addendum to Clinical Overview (ACO), and CO Authoring end to end Health-Hazard Assessment (HHA) documents for drug-only, Biologics, and medical device and combination product [MDCP] PQCs Attend Risk Management Committee (RMC) meeting for Signal management, query resolution, and medical inputs. Review of Medical Devices Design History Forms (DHFs) such as uFMEA, Hazard Analysis (HA), etc Medical to medical review Extensive literature search using various databases such as OVID (Medline and Embase), PubMed, MedRxiv, ClinicalTrial.gov.in, EUCTR, and Google Scholar as part of Literature Search CoE. Product Maintenance and Defense activities Reg21 Medical Assessment and product withdrawals, label updates, HA queries, CO, and ad-hoc scientific evidence search through effective literature searches Medical recommendation for Maximum Daily Dose Drug-Drug Interaction Slide decks Assisting Publication Writers in Scoping, Review, and Data extraction activities for Systematic Literature Reviews (SLRs). GenAI testing and PowerBI Infographics Assisting Senior Directors with all the Medical Affairs M&D activities.

Education

• Modern College of Pharmacy

  Bachelor of Pharmacy (BPharm), Pharmacy

  2006 — 2009

• Shivaji University, Kolhapur

  Doctor of Philosophy - PhD, Pharmacy (Pharmacology)

  2023 — 2026

• Dr. Antonio Da Silva Technical Junior College

  HSC, Science

  2002 — 2004

• Appasaheb Birnale College Of Pharmacy, Sangli

  Master of Pharmacy (MPharm), Pharmacology

  2009 — 2011

• MCE Society's Institute of Pharmacy

  Diploma in Pharmacy (DPharm), Pharmacy

  2004 — 2006

• Bangur Nagar Vidya Bhawan

  SSC, SSC

  2002