Dedicated Safety Aggregate Report Manager with 13 years of pharmacovigilance expertise, specializing in leading global teams and ensuring regulatory compliance. Proven track record in delivering high-quality aggregate reporting and signal management services to prominent clients.
Skilled in fostering strategic partnerships and to enhance project efficiency. Recognized for prioritizing staff development and succession planning, resulting in strong team retention and performance.
Committed to continuous improvement and patient safety advocacy. Adept at promoting workplace wellness initiatives. My leadership has led to successful project deliveries and enduring client relationships, driving impactful advancements in the pharmacovigilance industry.
Overview
13
13
years of professional experience
Work History
Manager - Safety Aggregate Report
IQVIA
12.2016 - Current
Leadership:
I serve as a stand-alone global lead for signal management project ad may need to jump to into the workflow as required to maintain compliance. I perform quality check of assigned signal management deliverables and provide consultative guidance to internal and external stakeholders. I act as a mentor to and coach to project team staff and direct line reports.
My responsibilities includes holding at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
PV scientist:
I also act as a PV scientist for a product or group of products in partnership with the Global Safety Officer (GSO) to evaluate safety data from multiple sources for assigned client’s products.
In collaboration with GSO, i coordinate, drafts and proposes responses to regulatory agencies or responses to inquiries from internal or external stakeholders. As a PVS, i act as a core member of the Safety Management Team (SMT) and manages end‑to‑end tracking of signals. As a SMT core member and coordinator, I am involved in the signal management, agenda setting, data outputs production, requesting contribution of all functions, preparing slide presentations, presenting in SMT (when necessary), facilitating discussions and documenting conclusions, and distributing draft and final minutes to SMT members.
I also support the GSO in conducting Safety Management Committee (SMC) meetings.
In collaboration with GSO, i perform end‑to‑end analysis and drafting of various safety reports (Safety Evaluation Report, response to HA) query/question.
I assist in the preparation and maintenance of the Company Core Data Sheet safety sections, and reviewing applicable sections of aggregate reports; PBRER, DSUR.
I represents pharmacovigilance on study teams, cross‑functional product teams, etc. when assigned as the delegate for the GSO.
Executive
Lambda Therapeutic Research Ltd.
12.2011 - 12.2016
I was associated with Lambda therapeutic research limited, Ahmedabad. During my working tenure, I was involved in the collection, preparation and finalization of aggregate reports including but not limited to Periodic Adverse Drug Experience Report (PADERs), PBRERs, PSURs, Addendum to Clinical overview summary report, Safety Summaries, RMP as per company’s-controlled documents.
I have also worked as a quality reviewer of individual case safety reports (ICSRs) and screening of worldwide scientific and medical literature.
I have also performed duties for vendor management.
<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC
Aggregate Manager / Operations Support Manager at APO LAND and QUARRY CORPORATION / APO CEMENT CORPORATIONAggregate Manager / Operations Support Manager at APO LAND and QUARRY CORPORATION / APO CEMENT CORPORATION