Aditya Shinde

About Aditya Shinde

With over 6 years of experience in the pharmacy sector and a specific focus on Pharmacovigilance, I have developed a deep understanding and expertise in ensuring the safety and efficacy of pharmaceutical products. My journey in this field has been marked by a dedication to thoroughness and accuracy, primarily in case processing that spans a diverse range of scenarios, including Vaccine, Regulatory, Clinical Trial, VAERS, and Booster dose cases. My proficiency with industry-standard databases and tools like Oracle Argus Safety Database 8.1.2, ARISg7 Database, and BioConnect, coupled with my competency in MS Office, empowers me to handle complex data with precision. I am adept at assessing event validity, causality, and seriousness, ensuring each report\'s consistency and completeness against source documents. In addition to my technical skills, I bring strong capabilities in health claim processing, auditing, and grievance resolution, honed through my experience in both US and Indian healthcare settings. My role as a Safety Science Coordinator at Fortrea (LabCorp)(Covance)(Sciformix) in Pune has further refined my skills in drafting legal and regulatory documents, managing regulatory cases, and contributing to continuous quality improvement. Core Competencies: • Pharmacovigilance & Drug Safety • Case Processing & Medical Coding • Database Management & Data Analysis • Adverse Event Reporting & Quality Assurance • Regulatory Compliance & SOP Writing • Stakeholder Communication & Team Collaboration As a dedicated professional in the field of Pharmacovigilance, my goal is to continuously contribute to pharmaceutical safety and quality assurance. I am eager to leverage my skills in a challenging environment that fosters professional growth and learning, with a focus on improving healthcare outcomes. I am always open to networking opportunities, professional collaborations, and discussions about the latest advancements in Pharmacovigilance and drug safety. Feel free to connect with me here on LinkedIn.

Experience

1. Safety Science Coordinator - Ii

   Fortrea

   Oct 2021 — Present · Pune, IN

   Conducting quality reviews of legal cases and processing various types of cases, including legal, non-medicinal, medicinal, and vaccine-related cases• Involvement in client projects, including reading and writing Standard Operating Procedures (SOPs)• Drafting legal and regulatory documents and handling regulatory cases, including those related to health authorities, clinical trials, business partners, literature, VAERS, C-Viper, and booster dose scenarios.• Serving as the primary contact for vaccine correction cases, as well as for matters related to attendance, productivity, translation activities, and follow-up requests• Evaluating the validity, causality, and seriousness of reported events • Successfully completing the quality reviewer training process

Education

• Maharashtra Institute of Pharmacy

  Bachelor of Pharmacy

• J.N.Petit Technical High School

  School