Cynthia Brown
Nutley,NJ
Summary
Dedicated professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Experienced in Clinical Trials, Medical Review for ICSR processing, Safety database audits and regulatory inspections to drive innovation and achieve company objectives.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Drug Safety Manager
Bayer Pharmaceuticals
06.2015 - Current
- Performs medical review of ICSRs (coding, expectedness, causality, seriousness, and narratives) to ensure quality and accurate reports
- Assisted in preparing the team for inspection readiness and audits
- Medical literature monitoring using Medline and PubMed
- Processing & reporting Adverse events into the Argus database for post- marketed and investigational products, including medical devices, literature and consumer care products
- Assisted in developing SOPs and training material when new and/or updated processes are introduced
- CRO oversight
- Assist in solution driven innovations to address areas needing improvements and adapt to system and process changes in order to increase efficiency, accuracy and improve overall compliance within the department.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Onboarded new employees with training and new hire documentation.
- Cross-trained existing employees to maximize team agility and performance.
Clinical Safety Scientist
Merck
07.2014 - 06.2015
- Prioritization of tasks based on level of urgency to ensure timely follow-up on ICSRs to maintain compliance to regulatory authorities
- Support the clinical team in the medical review of reportable event data to ensure that all information needed to support a sound medical case is obtained, including coordination of company causality assessment
- Generate safety queries to the study sites to resolve gaps and discrepancies in the data related to reportable events
- Provides individual case report input during MMT review of cumulative/aggregate review of SAE/ECI data
- Reconciles critical data points between clinical and safety database regarding reportable events and ensures inclusion of the 15 Quality Attributes.
- Contributing team member for the launch of Keytruda.
Quality Reviewer
Telerex (Sentrx Safety Solutions)-CRO
09.2012 - 06.2013
- Processing & reporting Adverse events for Client’s Marketed and Investigational products
- Responsible for Adverse event coding using standardized terminology from MedDRA
- Communicate professionally and directly with internal and external customers
- Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
- Reduced turnaround time for reviews by effectively prioritizing tasks and managing deadlines.
Drug Safety Associate
Schering Plough Pharmaceuticals
01.1998 - 04.2002
- Responsible for Adverse Drug Event reporting for foreign and domestic investigational and post-marketing products
- Assist in gathering Serious Adverse Events (SAEs) reports in a timely manner in the preparation of PSUR/DSUR, Product Safety and protocol guides
- Correlate database search to identify signaling issues and report them to Medical Monitors.
- Reconciled discrepancies found during adverse event data entry, resolving issues promptly while maintaining data integrity.
- Assisted in managing signal detection activities, helping identify potential emerging risks associated with marketed drugs.
Education
BS. Pharmacy -
St. John’s University
Registered pharmacist NJ
Skills
- Time Management
- Verbal and written communication
- Complex Problem-Solving
- Cross-Functional Teamwork
- Customer Service
- Hiring and Training
- Work Planning and Prioritization
Certification
American Pharmaceutical Association- Immunization Certification
American Red Cross - CPR Certified
Timeline
Drug Safety Manager
Bayer Pharmaceuticals
06.2015 - Current
Clinical Safety Scientist
Merck
07.2014 - 06.2015
Quality Reviewer
Telerex (Sentrx Safety Solutions)-CRO
09.2012 - 06.2013
Drug Safety Associate
Schering Plough Pharmaceuticals
01.1998 - 04.2002
BS. Pharmacy -
St. John’s University
Registered pharmacist NJ
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