Ashwini Mali

Pharmacovigilance Associate | Clinical data management| Data Analyst | and Expertise in Drug Safety, Case Processing, Regulatory Compliance, and Data Analysis | US healthcare executive

Role
Safety and Pv Specialist i at Syneos Health
Location
Pune, MH, IN
LinkedIn followers
500 followers
Research & DevelopmentView LinkedIn profile

About Ashwini Mali

As a dedicated Pharmacovigilance Associate with hands-on experience in drug safety and regulatory compliance, I bring a strong blend of technical expertise and a passion for ensuring patient safety. I specialize in safety database management using systems such as ARGUS, TALOSAFE, and ODYSSEY, along with scientific writing, medical coding (MedDra), and regulatory compliance. My focus on data analysis, including proficiency with tools like SAS, Python, and SQL, empowers me to deliver impactful insights and improve operational processes.I am experienced in CAPA implementation, literature review, and quality assurance, with a deep commitment to maintaining high standards in every project I tackle. With my solid background in clinical research and certifications in clinical research management, drug safety, and SAS programming, I am equipped to handle complex challenges in the pharmacovigilance and clinical research fields.I’m passionate about leveraging my skills in data analysis and time management to optimize workflows, support decision-making, and contribute to the success of research teams and projects. Constantly looking to expand my knowledge, I am eager to stay ahead of industry trends while maintaining a strong focus on patient safety and regulatory compliance.Certifications:Certified Drug Safety InternAdvanced Diploma in Clinical Research ManagementClinical Research E-internship as CRC/CRA InternHIPAARCMSAS Base & SAS SQLFeel free to connect with me if you\'d like to collaborate on impactful drug safety and clinical research initiatives.

Experience

  1. Safety and Pv Specialist i

    Syneos Health

    Apr 2025 — Present · Pune, IN

Education

  • Rajarshi shahu college of pharmacy

    Bachelor of Pharmacy - BPharm

    2017 — 2021

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Ashwini Mali — Safety and Pv Specialist i at Syneos Health in Pune, MH, IN | Unifers