Prashant Gore

About Prashant Gore

I’m a postgraduate in Pharmacology (M.Pharm) with 11 years of experience in Pharmacovigilance, primarily focused on oncology.Currently, I work as a Team Lead in Literature Surveillance at Cognizant, where I manage scientific literature review and monitoring activities to support global drug safety initiatives and regulatory requirements.In my current role, I lead a range of critical activities including: Training and mentoring team members Drafting and maintaining process documents (SOPs, SWIs) Handling audit and regulatory responses with a strong focus on compliance Supporting regulatory submissions and safety documentation Conducting root cause investigations (RCA) and implementing CAPA measures Designing and improving workflows based on evolving pharmacovigilance guidelinesI also hold: PG Diploma in Aggregate Reporting, Signal Detection, and Risk Management Plan (RMP) Japanese NAT (N5) Certification Two PubMed-indexed publications in peer-reviewed scientific journalsWith a strong interest in research, data analytics, and AI, I’ve transitioned into developing AI & NLP-based pharmacovigilance solutions that automate literature analysis and causality assessment. Currently building BioBERT-powered drug–adverse event causality detection systems integrated with FAERS databases, WHO-UMC/Naranjo algorithms, and regulatory reporting modules.These projects aim to enhance signal detection, reduce manual review time, and support regulatory compliance and decision-making in drug safety.I’m passionate about leveraging Artificial Intelligence and Machine Learning to advance pharmacovigilance automation, regulatory intelligence, and patient safety outcomes — combining domain depth with modern data science tools.For my complete list of research publications and academic work, visit my ResearchGate profile:

Experience

1. Tl-pharmacovigilance

   Cognizant

   Apr 2025 — Present · Mumbai, IN

   Collaborating with Global Safety Leads (GSLs), Therapeutic Area Heads, and client to ensure alignment on scientific literature reviews and expectations Developing and maintaining Standard Work Instructions (SWIs), Standard Operating Procedures (SOPs), and visual process flowcharts to streamline team operations Reviewing and analyzing scientific literature citations to identify relevant safety data and information Assessing citations for inclusion in aggregate safety reports, signal management activities, and other important safety information Overseeing technical challenges, managing team performance and quality metrics, addressing operational queries, and conducting team training—including training content and delivery oversight Collaborating with affiliate teams to update and refine local literature search strategies, keywords, Journal and product list. Managing citations in AI-driven databases to support accurate and compliant Medical Literature Monitoring.

Education

• R. C. Patel Institute of Pharmaceutical Education and Research

  M. Pharm, Pharmacology

  2013 — 2015

• Professional Training

  Certification in Data Science and Data Analytics, Data Science / Data Analytics

• St. John the Baptist High School and Junior College, Thane

  HSC, Higher Secondary Education

  2006 — 2008

• Bharati Vidyapeeth's College Of Pharmacy, Navi Mumbai

  Bachelor of Pharmacy (B. Pharm), Pharmacy

  2008 — 2012

Skills

• Biotechnology
• Pharmacovigilance
• Teamwork
• Clinical Research
• Clinical Trials
• Healthcare
• Pharmaceutical Industry
• Sop
• Drug Safety
• Lifesciences
• Medical Writing
• Pharmacology
• Leadership
• Research
• Life Sciences