
Nitin Kumar
Experienced Pharmacovigilance Professional Subject Matter Expert Training Representative Quality Management With over 7 years of expertise... | Chandigarh, Chandigarh, India
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Nitin Kumar’s Location Chandigarh, Chandigarh, India
Nitin Kumar’s Expertise Experienced Pharmacovigilance Professional Subject Matter Expert Training Representative Quality Management With over 7 years of expertise in Pharmacovigilance, I have honed my skills in end-to-end ICSR processing, including case intake, data entry, narrative writing, quality control, and submissions. My experience spans across multiple locations, including Mohali, Hyderabad, and the United States, where I have served as a Subject Matter Expert for a Hybrid team. As a dedicated training representative, I excel in preparing comprehensive training plans, conducting engaging sessions, and ensuring credit marks for participants. I am adept at maintaining training curriculums, tracking onboarding and offboarding of users, and managing organizational CV and JD assignments. My proficiency extends beyond operational aspects. I have a proven track record in writing and publishing controlled documents/SOPs, as well as maintaining regulatory intelligence reports. I possess extensive knowledge of reconciliation processes of ICSRs through various methods and have a keen eye for tracking compliance and distributing workload effectively. In addition to my role as a Subject Matter Expert, I have stepped up as a backup for Project Managers, showcasing my versatility and ability to handle diverse responsibilities. I take pride in my role as a mentor, providing guidance and training to new hires both at the project level and within the organization. Recognized three times consecutively by the Country Head for exceptional team performance, I am committed to delivering excellence in all aspects of my work. I possess hands-on experience in handling quality issues within the Quality system (TrackWise) and managing planned deviations, ensuring adherence to rigorous standards. If you are seeking a highly skilled and accomplished professional in Pharmacovigilance, I invite you to connect with me. Let's collaborate and drive impactful outcomes in the field of drug safety and regulatory compliance. Currently I am working as Inbound and Outbound Case Management Expert with one of the biggest pharmaceutical firm. Here I am handling oversight of multiple safety activities globally #Pharmacovigilance #SubjectMatterExpert #TrainingandDevelopment #QualityManagement
Nitin Kumar’s Current Industry Iqvia
Nitin
Kumar’s Prior Industry
Parexel
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Iqvia
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Work Experience

Iqvia
Operations Specialist 2 (Inbound & Outbound Case Management Expert)
Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Parexel
Senior Drug Safety Specialist
Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Parexel
Drug Safety Specialist
Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Parexel
Subject Matter Expert
Thu Oct 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Parexel
Drug Safety Associate II
Wed Jul 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Parexel
Pharmacovigilance analyst
Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Parexel
Pharmacovigilance scientist
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)