Functioning in a dual role, I pioneered daily project operations assisted by a team of 24, including quality and compliance of all project deliverables, including preparing project scope and objectives, activity planning, meeting deadlines, and milestones. I ensured the effective functioning of all assigned projects in compliance with client agreements, contracts, and local & global regulatory guidelines. I was primarily accountable for the initiation and maintenance of all technical agreements… Show more Functioning in a dual role, I pioneered daily project operations assisted by a team of 24, including quality and compliance of all project deliverables, including preparing project scope and objectives, activity planning, meeting deadlines, and milestones. I ensured the effective functioning of all assigned projects in compliance with client agreements, contracts, and local & global regulatory guidelines. I was primarily accountable for the initiation and maintenance of all technical agreements (TA), Pharmacovigilance Agreements (PVA), and SDEA and for generating, reviewing, and executing SOPs/WIs. As CAPA Owner, I ensured SLA-defined compliance by hosting internal & external audits and inspections. I actively represented the department across all client audits, regulatory authority inspections, and PSMF reviews. My role involved leading revenue projects, billing reports, and supporting the Presales team with RFPs. I led all quarterly meetings for LRPs with EU QPPV, monthly meetings with Australian QPPV, and other kick-off meetings. I proactively took part in internal project teams focused on improving processes within the Pharmacovigilance department and in external committees with other departments. I succeeded in 4 health authority inspections (US FDA) for a client with zero observations. I played a key role in conducting multiple trainings organization-wide and worked on multiple platforms. My success involved expanding the client base from 4 to 10 and all US FDA inspections and client audits. Show less

Overseeing all ICSR (Individual Case Safety Report) submissions to regulatory authorities, I submitted all reports on time, maintaining a consistent 100% compliance with submissions against the previous 96% with 3 team members, and was appreciated by the Global Head for the same. I was involved in processing case/s and reviewing the quality of ICSRs in Argus-Safety and expedited reports. Preparing PQ scripts for Argus-Safety validation and testing, along with assessment reports for product… Show more Overseeing all ICSR (Individual Case Safety Report) submissions to regulatory authorities, I submitted all reports on time, maintaining a consistent 100% compliance with submissions against the previous 96% with 3 team members, and was appreciated by the Global Head for the same. I was involved in processing case/s and reviewing the quality of ICSRs in Argus-Safety and expedited reports. Preparing PQ scripts for Argus-Safety validation and testing, along with assessment reports for product complaints, was my key area of responsibility. I proactively supported all US FDA and MHRA inspections. I was additionally involved in configuring products, licenses, and studies in Argus-Console. I played a pivotal role in training and mentoring team members on the latest developments and practices. I was involved in assessing listed cases with reports for multiple regulatory authorities and validity assessment and triage of received cases. Show less

As Training Manager, I trained more than 150 attendees on clinical research, clinical data management, and pharmacovigilance and developed >50 training aids and evaluation assessments. My role involved preparing study material for training and counseling and guiding prospective students on various aspects of the subject. My additional responsibility involved providing marketing consultation services as part of business promotion/development.

As a seasoned Coding Specialist/Lead for multiple clinical trials, I researched and resolved all coding-related issues and considerations by creating queries notifying relevant personnel/teams of coding discrepancies. I was full accountable for coding clinical and drug safety data (SAE & drugs), ensuring consistency, uniformity, and clarity across all data. I liaised with relevant authorities for verifying sponsors’ license requirements and attended audit and bid defense meetings. Participating… Show more As a seasoned Coding Specialist/Lead for multiple clinical trials, I researched and resolved all coding-related issues and considerations by creating queries notifying relevant personnel/teams of coding discrepancies. I was full accountable for coding clinical and drug safety data (SAE & drugs), ensuring consistency, uniformity, and clarity across all data. I liaised with relevant authorities for verifying sponsors’ license requirements and attended audit and bid defense meetings. Participating in Quick Start Camp, I cautiously identified coding requirements for sponsors and obtained sign-off and approval of clinical coding reports from the sponsor as per study timelines. I prepared and shared reported terms that cannot be coded to the Lead Data Manager/Drug Safety Manager for further disposition. My role involved reviewing ongoing auto-coded and interactively-coded clinical and safety data for accuracy and overall consistency. I significantly contributed to incorporating best coding practices and sponsor-specific guidelines by developing project-specific standards. As Clinical Coding Representative, I actively participated in team and sponsor meetings and shared coding expertise with all relevant parties, including sponsors. Show less

Directing a team of 62 Safety Associates on routine pharmacovigilance activities, I managed cases in the Oracle AERS database and assisted the Service Delivery Lead in preparing RFI/RFP responses and presentations for bid defense. Actively participating in internal data security audits, I initiated corrective measures post-audit findings ensuring compliance. Liaising with the Onsite team and client on project-related requirements and clarifications, I conducted medical reviews on safety cases… Show more Directing a team of 62 Safety Associates on routine pharmacovigilance activities, I managed cases in the Oracle AERS database and assisted the Service Delivery Lead in preparing RFI/RFP responses and presentations for bid defense. Actively participating in internal data security audits, I initiated corrective measures post-audit findings ensuring compliance. Liaising with the Onsite team and client on project-related requirements and clarifications, I conducted medical reviews on safety cases processed in the Oracle AERS database. While maintaining accurate records and metrics on cases processed, I presented daily status updates to the Project Manager. Supporting the Admin team, I handled the on/off-boarding of employees and trained new joinees on application and case assessment conventions and guidelines. I achieved huge success in winning the confidence and trust of a major US Pharma client for Pharmacovigilance, retaining the client for 3 consecutive years with no escalations, and completing a successful audit. I successfully expanded the team size from 4 to 60 for the above project and delivered the project within the agreed timelines and quality. Show less