Suraj Mallick

About Suraj Mallick

I am an M.Pharm graduate in Pharmaceutics with strong academic and research exposure across formulation development, advanced drug delivery systems, and regulated pharmaceutical environments. My interests lie in applying scientific knowledge, data integrity, and compliance-driven processes to support healthcare innovation and patient safety.My postgraduate thesis focused on the formulation, characterization, and optimization of a mucoadhesive nanoemulsion of Pimozide for intranasal nose-to-brain delivery, using Box–Behnken Design. The work involved formulation development, physicochemical characterization, in-vitro and in-vivo evaluation, and data interpretation to enhance brain targeting and bioavailability for CNS disorders.Beyond academics, I have actively contributed to scientific and academic communities, including serving as a Volunteer Coordinator for HEALTHMEDICON 2025, an international healthcare conference, where I supported session coordination, volunteer management, and smooth execution of academic and hybrid events. Core Skills & Exposure• Formulation development & optimization (DoE)• Advanced drug delivery systems (nanoemulsions, mucoadhesive systems)• In-vitro / in-vivo studies & scientific data analysis• Clinical data handling & documentation fundamentals• Pharmacovigilance & regulatory compliance basics (GxP)• SOP adherence, reporting & cross-functional coordination• Pharmaceutical & retail procurement and supply chain awarenessI am currently exploring opportunities across Formulation R&D, Clinical Data Management (CDM), Pharmacovigilance (PV), Regulatory Affairs (RA), and pharmaceutical/retail procurement and supply chain management, where I can contribute my technical foundation, analytical mindset, and commitment to quality and compliance while continuing to grow professionally. Open to entry-level and trainee roles | Research-driven | Compliance-focused | Adaptable

Experience

1. Pro Advance Diploma in Clinical Research

   LLRI - Learning Labb Research Institute

   Jan 2026 — Present · Bengaluru, IN

   Completed an industry-focused certification with comprehensive training in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, Medical Writing, and Clinical SAS, aligned with global regulatory standards.• Clinical Research: Knowledge of clinical trial phases (Phase I–IV), study protocol development, site feasibility, site initiation, monitoring, and close-out activities; well-versed in ICH-GCP, GCP compliance, informed consent (ICF), SAE reporting, and clinical trial documentation (TMF/eTMF).• Pharmacovigilance (PV): Hands-on training in ICSR processing, adverse event (AE) and serious adverse event (SAE) reporting, case triage, MedDRA coding, WHO-UMC causality assessment, signal detection, and global safety database concepts (Argus/ArisG).• Clinical Data Management (CDM): Experience in CRF/eCRF design, data entry validation, query generation & resolution, data cleaning, discrepancy management, database lock, and ensuring data integrity & quality control.• Regulatory Affairs (RA): Understanding of regulatory guidelines (USFDA, EMA, CDSCO), IND, NDA, ANDA processes, CTD/eCTD dossier preparation, labeling, and submission workflows.• Medical Writing: Skilled in clinical study reports (CSR), protocols, investigator brochures (IB), SOPs, literature reviews, and regulatory documentation following scientific and compliance standards.• Clinical SAS: Basic proficiency in SAS programming, including data step, PROC procedures, dataset creation, data cleaning, and generation of tables, listings, and figures (TLFs).

Education

• Adamas University

  Master of Pharmacy, Pharmaceutics and Drug Design

• Little Stars Senior Secondary School, Digboi

  Senior Secondary, Science (PCMB)

• Adamas University

  Bachelor of Pharmacy - BPharm, Pharmacy

• Vivekanand Kendra Vidyalaya, Kharsang

  Secondary