Accomplished, result focused professional with overall 8 years of experience in clinical, Drug safety and Pharmacovigilance with expertise in managing and delivering projects in Pre-marketing and Post- marketing drugs and devices clinical trials. Communicate and coordinate effectively with team members and instill high level of confidence at all levels with a commitment to team success and assignment at hand. Dedicated and fully committed to the highest level of excellence and quality to the ongoing objectives of the organization.
Spearheading project planning, executing and management. Organizing and providing end to end support for global clinical trials and safety activities. Ensuring adverse events (ICSR’s) are effectively monitored and processed. Ensuring regulatory compliance by submissions of reports within timelines. Budgeting, costing and allocation of resources for the projects. Drafting and finalizing of Safety data exchange agreements (SDEA) and safety management plans for upcoming projects. Supporting EU QPPV, profile creation and maintenance in Eudravigilance for Sponsors. Ensuring preparation and submission of annual safety reports -DSUR/PSUR. Ensuring the signal detection reports are prepared and submitted before timelines. Coordinating with Vendors and Pharmacovigilance System Master File maintenance (PSMF). Training and mentoring team on project related aspects. Client management and conducting project related meetings.
Project Management Operations Team Management Client Management Safety Databases (Argus, ArisG) ICSR Monitoring & Processing Medical Coding (MedDRA, WHODD) Medical Narrative Writing Regulatory Reporting Signal Detection THERAPEUTIC AREAS Cardiology Neurology Oncology Ophthalmology Rare Diseases Medical Devices
Awarded for delivering good quality and excellent performance. Appreciated for training and mentoring team members about the process.
Young, active, dynamic, professional, team player and a go getter.
I am ambitious and want to go up the ladder and reach high and good position.
I do not have anything as a ideal in my mind as long as the role is challenging and have opportunities to grow.
I would like to handle more projects and successfully deliver them to client so that I will be prepared to take on more complicated and expanded roles and responsibilities in the future, if and when they become available
Yes. I have been both a team player and independent contributor. And I am fine with both the roles.
I would like to take more challenging roles or high positions in management and also contribute all my skills and expertise for the development of organisation.
Demonstrated leadership and performed independently in a fast paced environment. Delivered to client within deadlines by effectively prioritizing and managing work. Headed and executed multiple projects simultaneously and smoothly. Directed team and achieved good productivity with excellent Quality. Awarded for delivering good quality and excellent performance. Appreciated for training and mentoring team members about the process.
Can be discussed at a later stage as it depends on role and also the location.
Yes. The domain which I am in requires to work extremely under pressure and also deadlines are very critical. I enjoy working under pressure and also learnt from my previous experience how to tackle it.