Clinical Trials and Medical Case Reports

Biography

Advance Diploma in Pharmacovigilance, Clinskill, 2019. Advance Professional (PG)Diploma (Clinical Trial Management), James Lind Institute, 2017. Ph.D. (Molecular Biosciences), University of Nottingham, UK,2012. M.Sc. (Biotechnology), Kumaon University, India, 2003. Government of India sponsored studentship. Advance Diploma in Computer Applications. UPTECH, India, 1998 AcceleronPharma,Cambridge,MA Sr. Manager, Safety Scientist. Responsible for the technical and scientific support for safety surveillance, signal detection and safety risk management activities. Responsible for the development of periodic (e.g. PBRER, DSUR, PADER) and ad-hoc safety reports for for submission to regulatory agencies. Collaborates with the safety surveillance team to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document using the procedures in place. Contribute to the evaluation of safety and responses to regulatory authorities. Contribute to the development of risk management plans (e.g. RMPs, REMs). Represent pharmacovigilance on cross-functional product/project teams as required. Represent pharmacovigilance for regulatory inspections and audits and contribute to the development of corrective action plans when needed. In collaboration with Safety Physician, plan and conduct Safety Management Team (SMT) meetings and track follow-up actions

Research Interest

Pharmacovigilance, Oncology