Parul Mishra

Experienced in the field of Pharmacovigilance, I am dedicated to ensuring global patient safety by conducting thorough safety surveillance and assessing the benefit-risk profile of both investigational and post-marketed medications. Skilled in analyzing clinical data and ICSRs, literature papers and identifying safety concerns and writing signal detection reports. Proficient in Pharmacovigilance, Good Clinical Practice (GCP), Clinical Trial Management System (CTMS), and Drug Development, I possess the necessary skills to effectively contribute to the field. Seeking opportunities to further develop knowledge and skills in the pharmaceutical industry. 
Being a conscientious, ambitious and enthusiastic individual, I have a desire to succeed in a challenging and stimulating environment. I have a wealth of exposure to drug safety and display plenty of initiative and am highly proactive. I have a rich array of key skills and enjoy researching and acquiring knowledge.

I possess 9 years of extensive experience in pharmacovigilance. I am well-versed in all aspects of ICSR workflows, including intake, case processing, peer reviewing, and QC before submissions. In my previous role in India, I successfully managed a team of 90 associates as a project coordinator, focusing primarily on the end-to-end process for new joiners, creating training plans, mentoring, and providing product and process-related training. In my previous role, I acted as a subject matter expert for studies, early access programs, and patient support programs. I was supporting QPPV office and PSMF whenever required. I have experience in handling CAPAs, internal audits, and inspection reports. I have played a significant role in training team members in various areas of pharmacovigilance. As an MI 1& MI 2 specialist, I was proficient in documenting MI and Adverse Event inquiries. 

I am a post-graduate in Pharmacy with a specialization in Pharmacognosy.