Dedicated and detail-oriented Pharmacovigilance Specialist with 8 years of experience in drug safety. Expert in regulatory compliance and risk management. Strong analytical and database management skills. Effective at enhancing team quality and training new hires.
Training and Mentoring
- TTT program participant; certified trainer.
- Trained new hires on COVID vaccine and biologic's.
- Mentored case processors and quality reviewers.
- Led focus group training for low-quality associates.
- Trained the team during database transitions
Team Leadership (Acting Team Lead)
- Managed daily operations; ensured project alignment.
- Supported team development.
- Made key decisions in the team lead’s absence.
- Facilitated cross-team communication.
ICSR Quality Review
- Reviewed ICSRs; provided quality feedback.
- Implemented quality improvement actions.
- Published quality metrics; identified trends.
- Designed training plans to enhance ICSR quality.
- Led daily huddles for CP quality updates.
Literature Case Processing
- Assessed literature for ICSRs and safety info.
- Managed translation requests and full-text orders.
- Ensured SLAs in daily work processes.
- Reassessed literature reviews; provided feedback.
- Handled book-in and triage for valid ICSRs.
ICSR Case Deletion
- Managed ICSR case deletions per guidelines.
- Maintained audit trails for regulatory support.
- Ensured compliance in all deletions.
ICSR Case Processing
- Processed ICSRs: entry, coding, narrative, follow-up.
- Handled cases involving cosmetics, antipsychotics, biologic's, and COVID vaccines.
Audit Activities
- Managed audit readiness and internal audits.
- Demonstrated case processing, quality review, and ICSR deletions.
Ad Hoc Activities
- Managed removal review at intake level
- Provided client support for process queries.