Dhru Patel
Fairless Hills,PA
Summary
Pharmacovigilance and product safety leader with over 8 years of experience in clinical trials and post-marketing surveillance. Expertise in developing and managing case intake operations, optimizing safety databases, and ensuring compliance with FDA and ICH regulations. Recognized for integrating safety and customer insights to improve benefit-risk evaluations and enhance data quality.
Overview
11
11
years of professional experience
Work History
Sr. Director, Product Safety & Consumer Insight
ByHeart, Inc.
New York City, NY
01.2025 - Current
- Oversaw fuctional departments spanning Product Safety and CX teams to ensure timely capture and escalation of adverse events, product complaints, and consumer health concerns across multiple channels.
- Developed and optimized intake workflows, training, and vendor management processes, improving case data quality, and reducing intake deviations by 50%.
- Oversaw the development and rollout of the production complaint management system, meeting FDA requirements.
- Directed inspection readiness activities, prepared documentation, and led internal audits that ensured compliance during external inspections.
- Implemented performance metrics and KPIs for CX teams, monitoring workflow timelines, and record completeness to meet reporting timelines.
- Oversaw deviation management, root cause analysis, and CAPA implementation to mitigate safety risks, and strengthen quality systems.
- Drove the Voice of the Customer (VOC) integration by embedding complaint insights into benefit–risk evaluations and corporate decision-making.
Director of Pharmacovigilance
ByHeart, Inc.
New York City, NY
12.2021 - 12.2024
- Built and developed the company’s first case intake and case management function, including system selection, workflow design, and UAT (User Acceptance Testing) for safety databases.
- Designed intake and triage workflows for adverse events and complaints, ensuring interconnectivity with CX channels, and seamless case handoff.
- Collaborated with IT, Quality, and Regulatory to establish compliant SOPs, training programs, and escalation pathways for safety case processing.
- Supported vendor onboarding and oversight, aligning external partners with ByHeart’s intake and reporting standards.
- Created and optimized case follow-up procedures with healthcare professionals and consumers, improving the completeness and timeliness of safety reporting.
- Established strong cross-functional relationships with CX, which demonstrated the integration of intake operations with customer experience, and ultimately led to ownership of the CX function.
Drug Safety Associate (Contract)
Johnson & Johnson
Cherry Hill, NJ
03.2021 - 11.2021
- Supported vaccine clinical trials and pipeline products, performing intake and triage of adverse events, and product complaints from healthcare professionals and patients.
- Ensured accurate, timely entry of safety data into clinical and post-marketing safety databases, in compliance with FDA/ICH guidelines.
- Trained post-marketing surveillance case processing teams on the safety profile of pipeline and clinical trial products, strengthening consistency in case evaluation.
- Collaborated with case processing teams to reconcile incomplete or missing clinical information, improving case quality, and regulatory compliance.
- Partnered with vendor intake teams, aligning external partners with J&J’s SOPs and pharmacovigilance standards for both clinical development and marketed products.
Safety Specialist
Novo Nordisk
Plainsboro, NJ
01.2019 - 01.2021
- Handled safety intake for diabetes and obesity therapeutic areas, coordinating with the call center, parents, and HCPs, ensuring data integrity.
- Conducted a safety follow-up with HCPs and patients, proactively obtaining missing clinical details for accurate case processing.
- Supported SDEA and pharmacovigilance agreement (PVA) activities, collaborating with cross-functional partners to ensure vendor compliance.
- Supported resolution of technical complaints by coordinating replacements, and providing patient education.
Licensed Team Lead, Medical Information
Ashfield Healthcare
Fort Washington, PA
02.2017 - 12.2018
- Led a medical information contact center team, overseeing the intake of inquiries, product complaints, and safety data from patients and providers.
- Trained and coached frontline agents in intake procedures, call handling, and compliance with FDA regulations, improving data accuracy and customer experience.
- Managed staffing and workflow for email medical information requests, reducing response times and improving service consistency.
Licensed Medical Information Specialist
Ashfield Healthcare
Fort Washington, PA
12.2014 - 02.2017
- Responded to medical information inquiries from healthcare professionals and patients, providing accurate, compliant information on both on-label and off-label use of products.
- Performed intake of adverse events (AEs) and product quality complaints (PQCs), ensuring timely and accurate documentation in safety databases, in accordance with FDA guidelines.
- Escalated complex inquiries and safety cases to appropriate cross-functional teams, ensuring alignment with regulatory and company standards.
- Maintained a high standard of call documentation, compliance, and customer experience, consistently meeting or exceeding quality benchmarks.
Education
MBA - Healthcare Management
Western Governors University
Salt Lake City, UT11-2023
Bachelor of Science - Nursing (RN)
Penn State University
07-2014
Skills
- Regulatory compliance
- Case management
- Data analysis
- Quality assurance
- Workflow design
- Vendor management
- Cross-functional collaboration
- Pharmacovigilance
- Attention to detail
References
References available upon request.
Timeline
Sr. Director, Product Safety & Consumer Insight
ByHeart, Inc.
01.2025 - Current
Director of Pharmacovigilance
ByHeart, Inc.
12.2021 - 12.2024
Drug Safety Associate (Contract)
Johnson & Johnson
03.2021 - 11.2021
Safety Specialist
Novo Nordisk
01.2019 - 01.2021
Licensed Team Lead, Medical Information
Ashfield Healthcare
02.2017 - 12.2018
Licensed Medical Information Specialist
Ashfield Healthcare
12.2014 - 02.2017
MBA - Healthcare Management
Western Governors University
Bachelor of Science - Nursing (RN)
Penn State University