Bhagyashree Patil
Pharmacovigilance Analyst | Expert in Adverse Event Reporting & Regulatory Compliance | Passionate about Enhancing Drug Safety & Patient Well-being
- Role
- Junior Data Analyst at Cognizant
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Bhagyashree Patil
Hi, I’m Bhagyashree, a passionate Pharmacovigilance Analyst with over four years of experience in ensuring pharmaceutical safety. At Cognizant, I\'ve managed over 1,500 Individual Case Safety Reports, collaborating with global teams to enhance compliance with regulatory standards like FDA and EMA. My expertise lies in MedDRA coding, literature surveillance, and efficient case processing, where I’ve improved entry efficiency by 10%.What sets me apart? I thrive in dynamic environments, embracing challenges with a detail-oriented and analytical mindset. I’m committed to continuous learning and improving processes, contributing to better healthcare outcomes. Let’s connect to explore how we can ensure safety together!
Experience
Junior Data Analyst
Jan 2021 — Present · Mumbai, IN
As a dedicated Pharmacovigilance Analyst, I play a pivotal role in ensuring the safety and efficacy of pharmaceutical products by meticulously processing and analyzing adverse event reports.Processed 1,500+ Individual Case Safety Reports (ICSRs): Leveraging my expertise, I managed a diverse array of serious and non-serious adverse event reports from healthcare professionals and regulatory bodies, enhancing our understanding of product safety and improving patient outcomes.Improved Case Entry Efficiency by 10%: By optimizing case processing in ARISg and Veeva Vault safety databases, I streamlined workflows and reduced processing time, enabling our team to respond more swiftly to safety concerns.Enhanced Case Closure Rates by 15%: Developed and managed targeted queries for incomplete ICSRs and product complaints, fostering clearer communication and expediting resolution processes, ultimately ensuring timely reporting to regulatory authorities.Triage and Prioritization of Literature Cases: Conducted thorough assessments of E2B R2/R3 cases and affiliate cases, ensuring adherence to Good Pharmacovigilance Practices (GVP). My proactive approach not only safeguarded compliance but also fortified our relationship with global regulatory authorities.Collaborated with Cross-Functional Teams: Engaged with internal teams and external regulatory bodies to facilitate timely case submissions, consistently ensuring compliance with FDA and EMA standards, and contributing to the overall safety of our pharmaceutical products.Performed Literature Surveillance and Data Analysis: Conducted in-depth reviews of medical journals and literature databases, documenting case findings that informed our safety protocols and risk management strategies.Contributed to Process Improvements: Actively participated in project team meetings and client calls, sharing insights that led to enhancements in compliance discussions and operational efficiencies.
Education
Saraswati Vidya Bhavans College of Pharmacy Sankara Nagar Shilpada Road Sonarpada Dombivli (East) Dist Thane-421 201
Bachler in Pharmacy , No
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