Komaldeep K. - 15853 Medical Writer from Mississauga

I am a Biochemistry postgraduate (Honors) (life science) with 3 years’ experience in pharmacovigilance, drug safety, regulatory affairs, medical writing, and medical information. Expertise in pharmacovigilance (PV) activities including processing and submission of Individual Case Safety Reports (ICSRs), Narrative writings and global pharmacovigilance regulatory affairs. Also took responsibility for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable. My key accountabilities included maintaining a good working knowledge of the adverse event safety profile, of the assigned drugs, labelling documents, client’s guidelines, and SOPs, and global drug safety regulations, organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting. Well-versed in scientific research with good working knowledge of GLP, experience as Junior Research Fellow in a national research laboratory, and Assistant Professor at renowned University. Looking forward to improvising my skill set and enhancing my personal and professional boundaries.