Cricket, Running
Hardik Trivedi
Manager - Safety Aggregate Report
Ahmedabad
Summary
- 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.
Education
M.Pharma -
Gujarat Technological Univeristy
Ahmedabad 04.2001 -
Skills
Team Leadership
Operations Management
Performance Management
Signal management
Interests
Timeline
Manager - Safety Aggregate Report
IQVIA
12.2016 - Current
Executive
Lambda Therapeutic Research Ltd.
12.2011 - 12.2016
M.Pharma -
Gujarat Technological Univeristy
04.2001 -
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