Neetu Chopra

About Neetu Chopra

I am a dynamic professional with 11 years of diverse experience, including 4 years in Pharmacovigilance (PV), 3.5 years as a Research Associate, and 3.5 years in Academics. I possess expertise in MedDRA coding, Oracle Argus drug safety database, literature review and have a thorough understanding of safety documentation, including Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR). My proven ability to contribute to drug safety and regulatory compliance is complemented by my proficiency in adhering to guidelines set by global health authorities, including the FDA and EMA, ensuring the highest standards of safety in drug development and post-marketing surveillance. I am skilled in conducting thorough safety data analyses, preparing comprehensive safety documents, and utilizing electronic reporting systems such as ARISg and Oracle Argus. As a collaborative team player, I excel in communicating effectively across cross-functional teams and have facilitated training sessions and presentations on safety protocols. My commitment to continuous improvement and upholding quality assurance practices within pharmacovigilance operations drives my dedication to maintaining excellence in all aspects of my work. I am now seeking to leverage my extensive experience to contribute to innovative drug safety initiatives in a challenging environment. You can reach me at n••••••••@gmail.com or +91••••••••15.

Experience

1. Safely and Pv Specialist i

   Syneos Health

   Jan 2022 — Present · Gurugram, IN

   Since January 2022, I have been working as a Safety & PV Specialist 1 at Syneos Health in Gurugram, India. In this role, I am responsible for literature review and entering information into Pharmacovigilance (PV) quality and tracking systems for the receipt and tracking of Individual Case Safety Reports (ICSRs). I assist in processing these reports according to Standard Operating Procedures (SOPs) and project-specific safety plans, ensuring that data integrity is maintained throughout the process. My responsibilities include entering data into the safety database, coding events, medical histories, concomitant medications, and tests. I compile complete narrative summaries and identify any information that requires queries, diligently following up until all queries are resolved. Additionally, I assist in the timely generation of expedited reports in accordance with applicable regulatory requirements. I ensure that all relevant documents are submitted to the Trial Master File (TMF) according to company SOPs and sponsor requirements for clinical trials. My role also involves maintaining a comprehensive understanding of and compliance with SOPs, Work Instructions (WIs), global drug, biologic, and device regulations, Good Clinical Practices (GCPs), ICH guidelines, and Good Pharmacovigilance Practices (GVP). This commitment to adherence not only supports regulatory compliance but also upholds the highest standards of safety in drug development

Education

• Guru Jambheshwar University

  Doctor of Philosophy - PhD

  2017 — 2020

• College of Pharmacy, Pt. B.D.Sharma, PGIMS, Rohtak

  M.pharmacy

  2011 — 2013

• Kurukshetra University

  B.pharmacy

  2007 — 2011