Asmita Titre

Strategic Pharmacovigilance Leader & Clinical Data Scientist with over 18 years of industry experience, defined by the intersection of clinical intuition and analytical precision. My career includes over 10 years in Pharmacovigilance Operations and 1.5 years as a Data Governance Lead, providing me with a unique vantage point on how data integrity fuels global safety.

My career is built on the conviction that safety data tells a story—but only if you have the right framework to interpret it. I lead global teams to move beyond "checkbox compliance," transforming Pharmacovigilance operations into a sophisticated, predictive strategy.

I act as the vital link between clinical expertise and technical innovation. By speaking the languages of both medical safety and data engineering, I optimize workflows for digital transformation while maintaining a rigorous focus on regulatory compliance. My goal is to ensure that while AI scales our efficiency, "human-in-the-loop" oversight remains the gold standard for detecting adverse events.

I solve the complex puzzles where Clinical Data, Patient Data Integrity, and Global ICSR Submissions converge. If you are looking to transition your safety operations from reactive reporting to proactive, AI-enabled surveillance—leveraging Global ICSR expertise—let’s connect.

Strategic Professional Summary

Strategic Pharmacovigilance Leader & Data Architect

18+ Years Industry Experience | Six Sigma Green Belt | B.H.M.S.

Results-driven leader with over 18 years of experience bridging the gap between clinical excellence, data governance, and large-scale PV operations. Specialist in Systems Life Cycle (SLC) management, overseeing global safety database configurations and AI-led automation to ensure inspection readiness. Proven track record in architecting data governance frameworks and leading high-performance teams through complex global transformations.

Expert at maintaining 98%+ compliance across FDA/EMA/MHRA frameworks while optimizing operational overhead through Business Process Re-engineering (BPR) and risk-based signal detection.

Professional Experience

Strategic Drug Safety Operations Lead

Qinecsa Solutions | [Remote, India] | Apr 2021 – Oct 2025

Strategic Oversight: Provided leadership across a global portfolio, overseeing Argus automation and vendor integration to scale clinical trial delivery.

Compliance & Quality: Achieved zero-finding inspection results by implementing rigorous CAPA management and advanced signal detection protocols.

Performance Leadership: Managed high-KPI global teams, driving a culture of continuous improvement and operational excellence.

Data Governance Lead

Healthivity Technology | [Mumbai, India] | Jan 2019 – Jun 2020

Data Strategy: Designed and enforced comprehensive data governance and DQ (Data Quality) rules for safety datasets.

Systems Mapping: Led the systems mapping strategy for a team of 50+ pharmacists, utilizing anomaly detection to ensure total data integrity.

Architecture: Acted as the bridge between PV business needs and technical IT delivery for cloud-based safety sets.

Team Lead, Pharmacovigilance

Cognizant Technology Solutions | [Mumbai, India] | Sep 2014 – Apr 2016

Operational Leadership: Headed a 25-member team managing complex QA workflows and database lifecycle activities.

Workflow Optimization: Managed end-to-end signal detection, ACK processing, and compliance training to ensure global regulatory alignment.

Talent Development: Mentored technical leads to transition from task-oriented to strategy-oriented delivery.

Senior Drug Safety Associate

Tata Consultancy Services | [Mumbai, India] | Jan 2011 – Sep 2014

Technical Execution: Processed high-volume ICSRs (Serious/Non-Serious) using EDC and global safety databases.

Portfolio Coverage: Managed clinical and post-marketing cases, including literature screening and medical data entry for global pharmaceutical clients.

Clinical Director / Practice Owner

Private Clinical Practice | [Mumbai, India] | Oct 2007 – Dec 2010

Business Leadership: Managed 800+ patients monthly while overseeing all aspects of clinical operations, patient safety, and business growth.

Patient Management: Leveraged clinical expertise to deliver outcomes-based treatment, scaling the practice through high patient retention and strategic referrals.

Homeopathic Physician

Dr. Batra’s Positive Health Clinic | [Mumbai, India] | Oct 2003 – Oct 2007

Clinical Operations: Provided specialized care for 1,300+ patients monthly in a high-throughput clinical environment.

Governance: Ensured strict adherence to clinical protocols and documentation standards while managing large-scale patient volumes.

Core Competencies

PV Systems: Argus, ArisG, Safety Database Configuration, SLC Management.

Data Science: Python, SQL, Anomaly Detection, AI-led Signal Detection.

Strategy: Mergers & Acquisitions Data Migration, BPR, Data Governance.

Certifications: Six Sigma Green Belt, Data Science Pro Degree.

Six Sigma Green Belt Certified (TUV SUD) – 2020 Data Science Pro Degree, Imarticus Learning, Mumbai – 2018 PGDCR (Clinical Research & Regulatory Affairs), Clinical Research Education & Management Academy, Mumbai – 2010 B.H.M.S, Chandaben Mohanbhai Patel Homoeopathic Medical College, Mumbai – 2003