Shubham Ghosh

About Shubham Ghosh

Shubham Ghosh Clinical Research Proffesional | Pharmacovigilance Professional | Narrative Writer | Complaints Handling Specialist Greetings! I\'m Shubham Ghosh, a dedicated professional with a passion for contributing to the healthcare and pharmaceutical industry. Currently, I am leveraging my skills and expertise as a Site Activation Coordinator at IQVIA, where I focus on site startup activities and documentation. My role involves working on various aspects of clinical trials, ensuring compliance with regulations and streamlining processes for efficient site activation. Career Highlights: At IQVIA, I have gained valuable experience in site startup activities, where I manage documentation and ensure adherence to protocols and regulations. My role also entails working with electronic Trial Master File (eTMF) systems such as Veeva Vault and Wingspan, as well as Clinical Trial Management Systems (CTMS), to track and manage trial documentation efficiently. Additionally, I\'ve effectively managed the upload and tracking of Clinical Trial Agreement (CTA) Processing. I have extensive experience in pre-Site Initiation Visit (SIV) tasks, data entry, reconciliation of missing documents, and composing site-specific FIle Review Pans (FRP) based on country and study regulations. My attention to detail and thorough understanding of regulatory requirements have been instrumental in ensuring the smooth initiation of clinical trials. Previous Experience: Prior to my current role, I worked at Cognizant as a Process Executive (Pharmacovigilance Associate), where I honed my skills in pharmacovigilance, complaint handling, and narrative writing. I played a key role in processing and coding adverse event cases, ensuring compliance with regulatory standards. My expertise in medical data analysis and summary writing contributed to the efficient handling of complaints and investigations. Educational Foundation: My academic journey is rooted in a strong foundation in pharmaceutical sciences. I earned my Bachelor of Pharmacy degree from the esteemed Gahlot Institute of Pharmacy. With expertise in Clinical Research and Pharmacovigilance, I bring a rich background and unwavering commitment to quality to the pharmaceutical industry. Let\'s connect on LinkedIn to stay in touch and engage in insightful discussions. My contact information - Email Id- g••••••••@gmail.com Phone number - 95••••••98

Experience

1. Site Activation Coordinator

   IQVIA

   Nov 2023 — Present · Thane, IN

   As a Site Activation Coordinator / Site File Admin at IQVIA, I engage in orchestrating site startup activities and meticulous documentation to ensure seamless initiation of clinical trials. My role involves leveraging my knowledge in electronic Trial Master File (eTMF) systems such as Veeva Vault, Medidata Rave and Wingspan, along with Clinical Trial Management Systems (CTMS), to streamline processes and enhance efficiency.Key Responsibilities- Manage and coordinate site startup activities to facilitate the smooth initiation of clinical trials- Utilize eTMF platforms including Veeva Vault and Wingspan, as well as CTMS, to track and manage trial documentation effectively- Perform pre-Site Initiation Visit (SIV) tasks, data entry, and reconciliation of missing documents to ensure regulatory compliance- Draft and compose site-specific Feasibility and Recruitment Plans (FRP) tailored to country and study regulations, optimizing trial success.Through my role, I contribute to the advancement of clinical research by ensuring adherence to protocols and regulations, ultimately supporting the delivery of innovative healthcare solutions.

Education

• Gahlot Institute Of Pharmacy , Koparkhairne

  Bachelor of Pharmacy - BPharm

  2016 — 2020

• Kendriya Vidyalaya Bhandup,Mumbai

  High School

  2009 — 2016