Dr. Ashok Yekasri

Pharmacovigilance and Drug Safety professional with 10+ years of experience across India and Canada supporting global pharmacovigilance operations, ICSR processing, aggregate safety reporting, PASR authoring, regulatory reporting, literature surveillance, compliance monitoring, quality management, audit readiness, and stakeholder collaboration. Extensive expertise in safety assessments, signal detection, KPI/KCI reporting, CAPA management, and compliance with ICH, FDA, EMA, Health Canada, GCP, and GVP requirements.

DRUG SAFETY ASSOCIATE - Cencora - Canada

(2024-06 - 2026-02)

• Managed end-to-end ICSR processing activities including intake, triage, quality review, medical review support, and case closure.
• Performed case assessments for seriousness, causality, expectedness, and regulatory reportability.
• Authored safety narratives, follow-up requests, reconciliation reports, and regulatory documentation.
• Coordinated cross-functional stakeholder meetings supporting PASR development and submission timelines.
• Managed PASR timelines, identified risks, and escalated delays to ensure on-time regulatory deliverables.
• Generated compliance metrics, KPIs, and KCIs to monitor performance and regulatory compliance.

PHARMACOVIGILANCE COORDINATOR - Shoppers Drug Mart - Canada

(2023-03 - 2024-06)

• Collaborated with Medical Directors, quality teams, CROs, and global stakeholders on safety deliverables.
• CAPA Initiation and deviations actions
• Developed source documentation for adverse events and product complaints.
• Supported preparation of safety reports and regulatory-compliant documentation.
• Maintained safety records and supported pharmacovigilance quality processes.
• Conducted reconciliation, compliance tracking, CAPA documentation, and root cause analysis.

SENIOR SAFETY SCIENCE SPECIALIST - Covance - India

(2018-09 - 2021-01)

• Authored detailed safety narratives and conducted clinical case assessments for global studies.
• Supported aggregate safety reporting activities including PASR, PSUR, DSUR, PBRER, and PASS deliverables.
• Collaborated with Therapeutic Area Safety Scientists and business partners to compile PASR contributions.
• Authored safety sections of PASRs and performed peer QC review of safety-authored content.
• Conducted literature review, literature surveillance, and safety signal evaluation activities.
• Reviewed published report versions and supported approval workflows.
• Participated in client meetings, audits, inspections, and process improvement initiatives.

SENIOR DRUG SAFETY ASSOCIATE - Bioclinica - India

(2016-08 - 2018-05)

• Reviewed and summarized medical literature across multiple therapeutic areas.
• Supported SOP development, regulatory documentation updates, and compliance activities.
• Performed quality review of safety documentation and literature surveillance outputs.
• Trained team members on safety documentation standards and quality expectations.

GLOBAL SAFETY & PV ASSISTANT I - Syneos Health - India

(2015-03 - 2016-07)

• Processed adverse event reports in accordance with ICH, FDA, and EMA requirements.
• Performed MedDRA coding, data validation, reconciliation, and compliance reporting.
• Maintained safety database records and ensured accuracy of case documentation.

PharmD - JSS University

PG Diploma - Pharmacovigilance - JSS University (2014-03 - 2014-03)

PG Diploma - Clinical Pharmacology - JSS University (2014-03 - 2014-03)

PG Diploma - Healthcare Administration & Management - Conestoga College