Shubham shinde

To enhance my professional skills, capabilities and knowledge in an organization which recognizes the value of hard work and trusts me with responsibilities and challenges.

Advance diploma in Pharmacovigilance and Clinical Research,From Elite Institute of Pharma Skills, Pune.

• Proficient in adverse drug reaction reporting, signal detection, risk management, safety monitoring, and regulatory compliance. Strong understanding of clinical research processes, including study design, protocol development, patient recruitment, and data collection and analysis.Skilled in conducting clinical trials and adhering to Good Clinical Practice (GCP) guidelines. Experienced in data management, adverse event reporting, and pharmacovigilance documentation.

Drug Regulatory Affairs Certification Course From Udemy.

• In-depth knowledge gained on drug development, regulatory frameworks, and submission procedures(ICH Guidelines,Drug Master Files(DMF),CTD,eCTD,Dossier preparation,Investigational New Drug (IND) and New Drug Application (NDA), FDA Regulation For Drug Product). Proficient in interpreting and implementing global regulatory guidelines. Adept at navigating complex regulatory landscapes for successful approvals. Detail-oriented, ensuring adherence to industry standards and guidelines. Dedicated to staying updated on evolving industry regulations. Equipped to facilitate smooth regulatory processes in the pharmaceutical sector.

Review on- Marine drug's used in treatment of cancer.

• Conducted a comprehensive review on marine drugs for cancer treatment, showcasing research and analytical skills. Explored mechanisms of action, efficacy, and current trends, demonstrating a nuanced understanding of the intersection between marine biology and medical science. This project underscores my ability to contribute innovative solutions in pharmaceutical and healthcare domains.

• Participated in UG Research project, 5th MET RX Plore 2020.
• Participated in Blood donation camp during 57th National Pharmacy Week, held by Indian Pharmaceutical Association.
• NSS active worker (successfully volunteered all the works given by college)
• Good at sports ( Antarang Kabaddi winner, tug of war runner-up, Carrom pool)

• Reading History books
• Capturing moments
• Traveling
• Avid listener of podcasts, cultivating a diverse range of knowledge and staying informed on industry trends and personal development topics."

I affirm that the aforementioned information is accurate to the best of my knowledge and belief. Given an opportunity, I am confident in showcasing my bright and capable mind.