SHIWANGI SINHA
Bengaluru
Summary
Dynamic Project Lead with extensive experience at Fortrea, excelling in end-to-end ICSR lifecycle management and CAPA implementation. Recognized for enhancing compliance and quality control, while mentoring teams to achieve operational excellence. Proficient in ARGUS Safety database and passionate about driving impactful pharmacovigilance solutions in regulated environments.
Overview
11
11
years of professional experience
Work History
Project Lead - Patient Safety Solutions (8+ Years)
Fortrea
01.2017 - Current
- Lead end-to-end pharmacovigilance operations ensuring compliance with global regulatory requirements and SOPs.
- Oversee full ICSR lifecycle including intake, triage, data entry, medical coding, narrative writing and QC using ARGUS Safety database.
- Manage workflow allocation, volume peaks, and resource planning to consistently meet regulatory timelines.
- Serve as CAPA and Root Cause Analysis (RCA) owner, identifying quality trends, conducting investigations, and implementing effective corrective and preventive actions.
- Ensure audit readiness and actively participate in internal, client, and regulatory audits.
- Conduct refresher trainings, daily huddles, and onboarding support for new joiners.
- Ensured compliant safety reporting per US and international regulations, SOPs, and client conventions.
- Prepared and reviewed Safety Management Plans (SMPs), reconciliation plans, and project-specific documentation.
- Generated and validated monthly metrics, dashboards, and project status reports.
- Performed end-to-end ICSR processing including duplicate checks, triage, data entry, follow-ups, and regulatory submissions.
- Executed medical coding using MedDRA, narrative writing, and case processing of all types of reports from various sources (Regulatory, Spontaneous, Clinical trial and literature).
- Conducted quality control reviews ensuring data integrity and regulatory compliance.
- Managed adverse event intake via safety mailboxes and contact center operations.
- Delivered refresher trainings, daily huddles, and onboarding support for new team members, strengthening team capability and compliance awareness.
- Mentored junior staff and provided technical guidance on complex cases, contributing to team performance and knowledge development.
- Recognized for strong ownership, compliance expertise, and consistent delivery of high-quality pharmacovigilance services in regulated environments.
- Formerly Labcorp
Analyst - Pharma Market Research
PharmaACE Analytics Pvt. Ltd.
Pune
07.2015 - 02.2017
- Conducted pharmaceutical market research covering company profiles, pipeline products, clinical trials, and competitive intelligence.
- Developed target market profiles and strategic insights for pharmaceutical clients.
- Prepared high-impact reports and presentations on collaborations, partnerships, and market outlook.
Education
Bachelor of Pharmacy -
Indira College of Pharmacy
PuneAdvanced PG Diploma - Clinical Research & Pharmacovigilance
Cliniminds
PuneSkills
- End-to-End ICSR Lifecycle Management
- Case Intake
- Triage & Prioritization
- Quality Control (QC)
- Peer Review
- Audit & Inspection Readiness
- Client Communication
- Reconciliation Activities
- ARGUS Safety Database - GPV Modules
- Medical Coding (MedDRA)
- Narrative Writing
- CAPA
- Root Cause Analysis (RCA)
- Drug Safety Mailbox
- Contact Center Operations
- Team Training
- Mentoring
- Workflow Management
Accomplishments
Outstanding Performance Award
Roll of Honor Award
Client Appreciation Award
Audit Excellence Award
Star Performer Award
Roll of Honor Award
Client Appreciation Award
Audit Excellence Award
Star Performer Award
Systems And Tools
- ARGUS Safety (GPV Module)
- MedDRA
- TrackWise QMS
Languages
- English, Full Professional Proficiency
- Hindi, Native/Bilingual
Timeline
Project Lead - Patient Safety Solutions (8+ Years)
Fortrea
01.2017 - Current
Analyst - Pharma Market Research
PharmaACE Analytics Pvt. Ltd.
07.2015 - 02.2017
Bachelor of Pharmacy -
Indira College of Pharmacy
Advanced PG Diploma - Clinical Research & Pharmacovigilance
Cliniminds