Varsha Gaikwad

WORK HISTORY

EDUCATION

ABOUT VARSHA GAIKWAD

A competent, efficient, and result-oriented professional with research experience who is responsible for evaluating the safety of pharmaceutical drugs once they have been introduced to the market. A strategic thinker with a track record of developing plans for managing daily drug safety operations, including the management of in-house Serious Adverse Event (SAE) case processing and external pharmacovigilance vendors; coordinates with data management staff concerning the reconciliation of safety data between the clinical and safety databases; presenting, evaluating, and recommending prospects to senior-level decision-makers; gaining control of crucial issue areas and meeting client obligations; Excellent interpersonal, organizational, and communication skills, with a track record of managing motivated teams to achieve organizational objectives.PROFILE SUMMARY• Manage day-to-day drug safety activities, including in-house case processing and external pharmacovigilance suppliers. • Detailed understanding of global regulatory requirements for Pharmacovigilance (FDA, GVP, and ICH guidelines) • Received, triaged, reviewed and processed Lifecycle Safety data from various sources on time, within budget and quality standards.• Performed data entry for tracking and Lifecycle Safety databases, coded relevant medical terminology, wrote descript narratives, generated queries pertinent to the case, performed quality control, assisted with reconciliation, case closure, coordinated translations and ensured reports are sent to the customer within assigned deadlines.• Processed Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.• Mentored less experienced or newer staff members. Provided oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects.• Participated in training across Lifecycle Safety service offerings. Provided project-specific operational process training to junior team members.