Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Heather Nordlinger

Fort Washington,PA

Summary

Dynamic Senior Drug Safety Associate skilled in managing complex case processing, mentoring teams, and driving process improvements. Adept at collaborating with global partners to ensure high-quality reporting and compliance in pharmacovigilance.

Overview

16
16
years of professional experience

Work History

Senior Drug Safety Associate

Johnson & Johnson
Horsham, Pennsylvania
05.2018 - Current
  • Ensured data accuracy, compliance, and timely reporting for adverse event case processing.
  • Collaborated with global teams and vendors to maintain high case quality and streamline workflows.
  • Supervised and mentored staff, driving process improvements for enhanced safety data quality.
  • Managed complex serious cases while supporting clinical trial safety activities and regulatory submissions.

Drug Safety Specialist

Teva Pharmaceuticals
Horsham, Pennsylvania
03.2009 - 04.2018
  • Performed adverse event data entry, quality control, and follow-up activities for post-marketing products to ensure accuracy and compliance.
  • Led training and mentored new team members, providing ongoing support.
  • Managed the review of legal and literature cases, serving as the primary point of contact for legal cases.
  • Prepared and compiled periodic reports for FDA submissions, ensuring timely and accurate documentation.

Education

Bachelor of Science - Nursing

Temple University
Philadelphia, PA
05-1998

Skills

  • data accuracy
  • adverse event reporting
  • regulatory compliance
  • effective communication
  • Teamwork and collaboration
  • Pharmacovigilance expertise
  • Project management capabilities
  • Team leadership qualities
  • Critical thinking capacity
  • Quality assurance practices
  • Clinical trials
  • Case processing experience

References

References available upon request.

Timeline

Senior Drug Safety Associate

Johnson & Johnson
05.2018 - Current

Drug Safety Specialist

Teva Pharmaceuticals
03.2009 - 04.2018

Bachelor of Science - Nursing

Temple University