Developed expertise in Post Market Surveillance activities covering various therapeutic areas (Osteoporotic product, Diabetic products, Reproductive disorder products) and work included:• Case processing of various type of cases including cases associated with product complaints (Serious/Non-serious, Pregnancy, Social media cases, Market research, Spontaneous, Business partner case) reported either spontaneously or solicited that involved prompt identification, timely investigation, narrative writing for product related death, serious injury and non-serious reports.• Triaging of reports-Book-in, assessment of seriousness and other aspects and finally routing to appropriate workflow.• Narrative writing of safety reports.• Analysis and processing of product complaints in safety database.• Works closely with Sales Representatives, affiliates, and health care professionals to obtain additional information needed for completion of safety report.• Involved in quality review of all types of cases (literature, clinical trial, post marketing, spontaneous) of team members. Provided mentorship and training support to improve overall quality.• Involved in training and mentoring to new joiners.• Involved in accreditation review for new joiners and peer review.• Handling team queries and involved in trend analysis activities.• Involved in workshops needed for improvement the case processing understanding of team.• Case processing related activities (Action items, follow up process etc.)• Maintained understanding and compliance with SOPs, project, and client requirement.• Working on Safety database (Oracle Argus 8.1.2).• Therapeutic area experiences include Osteoporotic product, Diabetic products, Reproductive disorder products.• Knowledge of Minitab software (statistical and graphical analysis software) for trend analysis.

• During training I have learnt & experienced various aspects of clinical research. • Maintained study master files including all essential documents(investigation brochure, protocol, EC approval, consent document etc.)• Understood the importance & functioning of Ethics committee in clinical trials• Supported in scheduling of IRB, EC meeting by coordinating ,preparing agenda, preparation of EC approval letters. Assisted in preparation of dossier/application as per regulatory guidelines and its dispatch prior to the EC meetings.• Reviewed the CIOMS form (suspect adverse action report).

Worked as a Science teacher

Worked in DRDO, Delhi for 6 months as a project trainee during post-graduation. Worked as a team member in a team of 4 persons. My work included growing of the Bacillus species in artificial environment. I studied the effect of Gamma radiation on the Biomolecules. The work also involved the use of Semiquinone derivative to protect the biomolecules from Gamma radiation.