Dr. Prashanth BSB
Head – Safety and Medical writing
Dr Prashanth is Head of Safety and Medical writing for ELC GROUP. Prior to joining our team, Dr Prashanth held senior pharmacovigilance and medical safety positions at several global pharmaceutical companies.
He has a wide experience in developing and maintaining pharmacovigilance systems and has successfully managed their compliance through various inspections. His pharmacovigilance expertise incudes ensuring appropriate medical information system, providing medical and safety advice to cross-functional teams and delivering regulatory compliant PSURs/PBRER/RMPs.
In medical writing, Dr Prashanth’s responsibilities have included reviewing and approving responses prepared for health authorities, clinical and non-clinical overviews for EU Marketing Authorisation Applications (MAAs), and clinical expert statements.
He has an extensive experience in designing strategy for clinical trials and pharmacokinetics studies. He has participated in various investigators’ meetings and provided inputs for clinical protocols and study reports. He has coordinated numerous clinical trials exploring the efficacy and safety of therapeutic medication for asthma, COPD, cancer and autoimmune diseases.
Dr Prashanth holds a medical degree from Mysore Medical College & Research Institute, India. He additionally holds a post-graduation in Clinical Research and Regulatory Affairs.