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.
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Executive Administrative Assistant at Johnson & Johnson - Strategy & Business Services, Global ServicesExecutive Administrative Assistant at Johnson & Johnson - Strategy & Business Services, Global Services