Pharmacovigilance Expert | Safety Risk Management
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I'm Ohan Jade Dsouza, a highly skilled Drug Safety Specialist with over 6 years of expertise in end-to-end case processing, adhering to GCP/GVP/ICH guidelines. I am passionate about ensuring patient safety and driving excellence in the pharmaceutical industry.
Throughout my career, I have orchestrated the efficient management of 5,000+ adverse event cases, delivering a flawless 100% on-time completion rate. Leveraging advanced pharmacovigilance software such as Argus Safety, Sapphire, and ArisG, I have optimized monitoring and reporting processes, resulting in enhanced efficiency and accuracy.
Maintaining unwavering compliance during FDA, Health Canada, and EMA audits is a top priority for me. I have consistently achieved a perfect record, demonstrating my commitment to upholding regulatory standards. Moreover, I take pride in attaining a remarkable 98% accuracy rate in safety narratives, reducing errors by 20% and ensuring reliable documentation.
Collaboration and stakeholder partnerships are essential aspects of my work. I have closely collaborated with L&D teams to develop cutting-edge training programs, fostering continuous learning and professional growth. Additionally, I believe in building fruitful relationships with stakeholders to drive shared goals and outcomes.
Here are some of my key skills: Pharmacovigilance, Patient Safety, GVP (Good Pharmacovigilance Practices), GMP (Good Manufacturing Practices), Adverse Event Management, Regulatory Compliance, Process Improvement, Customer Service, Critical Thinking, Written Communication, Collaboration, Attention to Detail, and proficiency in Powerpoint, Excel, Market Product Coding, and Databases.
In my previous roles, I have demonstrated exceptional performance and leadership. As a Senior Drug Safety Associate at Qinecsa Solutions, I streamlined end-to-end case processing, resulting in a 100% compliance rate during audits. I also conducted PV training sessions, enhancing awareness and adherence to best practices.
During my tenure as a Patient Safety Specialist Plus at Tata Consultancy Services, I achieved exceptional accuracy in processing 4,500 case reports within 2 months. I effectively addressed non-compliance and ensured on-time submissions while leading a high-performing team.
As a Junior Drug Safety Associate at Sciformix Technologies, I facilitated the compilation of ADRs, conducted adverse event investigations, and maintained strict adherence to PV regulations and guidelines
I'm Ohan Jade Dsouza, a highly skilled Drug Safety Specialist with over 6 years of expertise in end-to-end case processing, adhering to GCP/GVP/ICH guidelines. I am passionate about ensuring patient safety and driving excellence in the pharmaceutical industry.
Throughout my career, I have orchestrated the efficient management of 5,000+ adverse event cases, delivering a flawless 100% on-time completion rate. Leveraging advanced pharmacovigilance software such as Argus Safety, Sapphire, and ArisG, I have optimized monitoring and reporting processes, resulting in enhanced efficiency and accuracy.
Maintaining unwavering compliance during FDA, Health Canada, and EMA audits is a top priority for me. I have consistently achieved a perfect record, demonstrating my commitment to upholding regulatory standards. Moreover, I take pride in attaining a remarkable 98% accuracy rate in safety narratives, reducing errors by 20% and ensuring reliable documentation.
Collaboration and stakeholder partnerships are essential aspects of my work. I have closely collaborated with L&D teams to develop cutting-edge training programs, fostering continuous learning and professional growth. Additionally, I believe in building fruitful relationships with stakeholders to drive shared goals and outcomes.
Here are some of my key skills: Pharmacovigilance, Patient Safety, GVP (Good Pharmacovigilance Practices), GMP (Good Manufacturing Practices), Adverse Event Management, Regulatory Compliance, Process Improvement, Customer Service, Critical Thinking, Written Communication, Collaboration, Attention to Detail, and proficiency in Powerpoint, Excel, Market Product Coding, and Databases.
In my previous roles, I have demonstrated exceptional performance and leadership. As a Senior Drug Safety Associate at Qinecsa Solutions, I streamlined end-to-end case processing, resulting in a 100% compliance rate during audits. I also conducted PV training sessions, enhancing awareness and adherence to best practices.
During my tenure as a Patient Safety Specialist Plus at Tata Consultancy Services, I achieved exceptional accuracy in processing 4,500 case reports within 2 months. I effectively addressed non-compliance and ensured on-time submissions while leading a high-performing team.
As a Junior Drug Safety Associate at Sciformix Technologies, I facilitated the compilation of ADRs, conducted adverse event investigations, and maintained strict adherence to PV regulations and guidelines
Master of Pharmacy, Major in Pharmacology University of Pune, Pune, India August 2015 - May 2017 GPA: 4.2
