Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
Generic

ASHWINI CHAVAN

Pune

Summary

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.

Overview

8
8
years of professional experience

Work History

Lead Safety Science Specialist (Pharmacovigilance)

Fortrea
Pune
10.2016 - Current

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.

Marketing Executive

Mrudul Hearing Aid Centre
Mumbai
07.2012
  • Planned and developed marketing activities, Represented the company at ENT conferences, Counseled patients

Education

MBA Marketing -

AMSIMR Ghatkopar
Mumbai
01.2011

B.Pharma -

Birnale college Shivaji University
01.2009

Skills

  • Training & Mentoring
  • ICSR Quality Review
  • Literature Case Processing
  • ICSR Case Processing
  • ICSR Case Deletion Management
  • Audit Management
  • Ad Hoc Support Activities
  • Team Leadership (Acting Team Lead)
  • Project Management

Accomplishments

  • Many times, awarded with SMART card for monthly quality and productivity.
  • Received certification with trophy for contribution in maximum productivity during database transition

Languages

  • English
  • Marathi
  • Hindi

Timeline

Lead Safety Science Specialist (Pharmacovigilance)

Fortrea
10.2016 - Current

Marketing Executive

Mrudul Hearing Aid Centre
07.2012

MBA Marketing -

AMSIMR Ghatkopar

B.Pharma -

Birnale college Shivaji University
ASHWINI CHAVAN