Deepika Saini
Cambridge,UK
Summary
Pharmacovigilance and Drug Safety professional with 11+ years of experience delivering compliant, high-quality ICSR operations across global environments. Expertise in Argus Safety, MedDRA coding, literature screening, and end-to-end case processing in line with ICH and EU GVP guidelines. Proven track record in leading teams, supporting audits and Health Authority inspections, and driving measurable quality improvements through RCA, CAPA and Effectiveness Checks. Combines hands-on operational excellence with leadership in client engagement, process optimisation, and quality management systems (TrackWise, Intelex). Experienced in SOP development, risk management, and training delivery to strengthen team capability and compliance culture. Recognised for reliability in fast-paced, regulated settings, with a consistent focus on accuracy, efficiency, and regulatory adherence.
Overview
11
11
years of professional experience
Work history
Lead, Safety Operations
EVERSANA
Pune
2024.07 - 2025.04
- Led a high-performing pharmacovigilance team managing large-scale ICSR operations; acted as primary client interface, ensuring KPI adherence, regulatory compliance, and operational excellence.
- Supported client audits and regulatory inspections, maintaining continuous inspection readiness.
- Led automation of follow-up processes improving turnaround time and operational efficiency.
- Performed ICSR processing, quality review and follow-ups utilizing Argus, ensuring compliance with global reporting timelines and data quality standards.
- Conducted Root Cause Analysis (RCA) and implemented CAPA and performed effectiveness checks, contributing to a significant reduction in quality and process deviations.
- Oversaw QMS platforms (TrackWise, Intelex), ensuring adherence to internal and regulatory quality frameworks.
- Developed and implemented SOPs and Work Instructions aligned with GVP, ICH and global pharmacovigilance requirements.
- Designed and implemented Quality Improvement Plans, achieving a 70% reduction in overall quality and process deviations.
- Maintained quarterly risk registers for clients, identifying and mitigating operational risks to enhance compliance and operational stability.
- Managed resource planning, recruitment, onboarding, performance management, and maintained attendance, payroll, and leave records for team members.
Manager, Pharmacovigilance Operations
Parexel International India Pvt LTD
Mohali
2022.04 - 2024.06
- Managed end-to-end ICSR operations across global clients.
- Supported client ramp-up operations handling ~300,000 cases annually.
- Led teams ensuring KPI, quality, and compliance adherence.
- Supported audits, inspections, and regulatory authority responses.
- Drove process improvements and quality enhancement initiatives.
Associate Manager, Pharmacovigilance Operations
Parexel International India Pvt LTD
Mohali
2020.01 - 2022.03
- Oversaw pharmacovigilance case processing and operational delivery.
- Ensured compliance with regulatory timelines and internal quality standards.
- Supported client deliverables and operational governance activities.
Pharmacovigilance Specialist
Parexel International India Pvt LTD
Mohali
2017.11 - 2019.12
- Performed end-to-end ICSR processing (spontaneous, clinical trial, literature cases) and ensured compliance with global reporting timelines.
- Conducted systematic literature searches using PubMed to identify potential ICSRs and safety signals; performed screening and documentation in line with ICH guidelines. Conducted safety triage and case quality review activities.
- Extensive hands-on experience with Argus safety databases.
- Experienced in case validation, follow-up, and documentation as per PV guidelines.
Pharmacovigilance Analyst
Parexel International India Pvt LTD
Mohali
2015.04 - 2017.10
- Performed ICSR processing activities. Performed MedDRA coding, data entry, and case follow-ups.
- Assisted in quality checks and compliance documentation.
- Successfully delivered on tasks within tight deadlines.
Pharmacovigilance Scientist
Quantum Solutions India
Chandigarh
2014.02 - 2015.03
- Supported safety case processing and evaluation activities using Argus and AWARE databases.
- Assisted in literature screening and adverse event documentation.
- Carried out day-to-day duties accurately and efficiently.
Education
Master of Pharmacy - Pharmacology
Punjab Technical University
India 2011.01 - /2013
Skills
- Pharmacovigilance Operations (ICSR – all case types)
- Audit & Inspection Readiness
- Quality Management Systems (TrackWise, Intelex)
- Root Cause Analysis (RCA) & CAPA
- Team Leadership & People Management
- Client & Stakeholder Management
- Work Capacity & Resource Planning
- Safety Data Processing, MedDRA coding & Quality Review
- Argus Safety Database
- Literature Searches & Signal Detection
- Regulatory Compliance (ICH, GVP modules)
- Risk Management & Risk Registers
- SOP and Work Instructions Development
- Training & Capability Building
- Continuous process improvement
TRAINING & MENTORING EXPERIENCE
- Designed and delivered role-based pharmacovigilance trainings, including refresher and process-specific sessions aligned with global regulatory requirements.
- Developed training materials, assessments, and SOP-linked learning content.
- Managed training compliance using LMS – Learning Management System.
- Mentored associates in ICSR processing, quality standards, and regulatory compliance.
Accomplishments
- Employee of the Quarter
- Peer Recognition Award
- Quality Event Champion Award
- – 4 consecutive times
- Recognized for exceptional performance, dedication, and contribution to organizational goals
Timeline
Lead, Safety Operations
EVERSANA
2024.07 - 2025.04
Manager, Pharmacovigilance Operations
Parexel International India Pvt LTD
2022.04 - 2024.06
Associate Manager, Pharmacovigilance Operations
Parexel International India Pvt LTD
2020.01 - 2022.03
Pharmacovigilance Specialist
Parexel International India Pvt LTD
2017.11 - 2019.12
Pharmacovigilance Analyst
Parexel International India Pvt LTD
2015.04 - 2017.10
Pharmacovigilance Scientist
Quantum Solutions India
2014.02 - 2015.03
Master of Pharmacy - Pharmacology
Punjab Technical University
2011.01 - /2013