Manik Roy

Background

About Manik Roy

I am Pharmacovigilance (PV) professional with more than 9 years of experience which includes Project Management (Pharmacovigilance activities), line management, authoring and QC of complete aggregate reports along with Benefit-Risk analysis sections (PBRERs, DSURs), health authority query responses (ATOs, PRAC responses), RMPs and SBRs. I have overall experience of performing different activities of pharmacovigilance in the pharmaceutical industry. Active participation of developing and improvement of PSR & Safety commitment tracking tool. Started my pharmacovigilance career with processing of SAEs from the oncology trials, preparation of CIOMS, reconciliation of SAEs with the clinical database. Prepared number of PV department SOP, involved in the successful implementation procedure of ARISg safety database; active role in communication between our team & vendor, scheduling the meetings and training whenever required. Performed and prepared the report of user acceptance test (UAT) for ARISg safety database. Performed and involved in the communication of safety data with other party as per SDEAs. Also involved in the evaluation of the AE/SAE page of clinical database, one of the point of contact from the drug safety team for the company sponsored clinical trials. Colleagues know me as a hardworking and efficient employee. Received award of excellence form the organisation for outstanding performance and accomplishment. I completed my Master of pharmacy in the year April 2012 form The Tamil Nadu Dr. M.G.R. Medical university, Chennai, Tamil Nadu, India (Institute: College of pharmacy SRIPMs, Coimbatore, Tamil Nadu).