A medical practitioner, with 10+ years of experience in drug safety/pharmacovigilance, and 3+ years of clinical practice, with profound clinical judgment, and proficiency in multiple therapeutic areas. Experienced in quality review/medical assessment of ICSRs and aggregate safety reports, clinical trials safety signal management and post-approval surveillance. Scientifically and medically minded, with the ability to interpret case information utilizing clinical judgment skills, and proven ability to evaluate clinical data.Expert in writing and reviewing safety sections of aggregate reports (PBRERs, PADERs, DSURs, SERs & SUSARs) drafting response to regulatory questions, analyzing data for possible signals (signal detection), representing safety science team, safety team meetings, performing literature triage and review.Trained in the field of PV including ICH GCP guidelines, MedDRA dictionary, various GVP modules and reference safety information documents. Additional responsibilities include training and evaluating drug safety associates and specialists for medical writing.