Summary
Overview
Work History
Education
Skills
Timeline
Generic
M E R I A M F . C A N A R E S

M E R I A M F . C A N A R E S

SOMERVILLE,NJ

Summary

  • Results-driven Senior Clinical Safety Leader with a background in leading cross-functional teams to ensure compliance and improve patient safety outcomes.
  • Highly skilled Senior Clinical Safety Leader with expertise in adverse event management and pharmacovigilance, driving successful safety initiatives.
  • Dynamic Senior Clinical Safety Leader with a strong background in clinical trial safety management and regulatory compliance, adept at leading safety programs.
  • Experienced clinical safety professional with a strong background in pharmacovigilance and adverse event management.
  • Skilled pharmacovigilance lead with a proven track record of ensuring regulatory compliance and patient safety.
  • Detail-oriented clinical safety specialist with expertise in risk management and signal detection.
  • Dynamic pharmacovigilance professional with a focus on continuous improvement and quality assurance in drug safety processes.
  • Highly experienced Senior Clinical Safety Leader with a proven track record of ensuring compliance with safety regulations and guidelines.
  • Proficient Clinical Safety Leader with a strong background in conducting safety assessments and implementing risk management strategies.
  • Strategic and detail-oriented Senior Clinical Safety Leader adept at leading cross-functional teams and developing safety monitoring plans.
  • Dynamic Senior Clinical Safety Leader with extensive experience in pharmacovigilance and signal detection, committed to promoting patient safety and regulatory compliance.

Overview

34
34
years of professional experience

Work History

SENIOR CLINICAL SAFETY LEADER

Sanofi
10.2018 - 04.2024
  • Led global pharmacovigilance team in safety monitoring activities for multiple clinical trials
  • Managed safety data review and analysis for global drug development programs
  • Collaborated with cross-functional teams to ensure compliance with safety regulations
  • Developed and implemented risk management strategies for investigational drugs
  • Conducted safety assessments and prepared regulatory submissions for new drug applications
  • Provided oversight for signal detection and risk assessment activities
  • Contributed to safety monitoring and risk mitigation plans for clinical studies
  • Reviewed and interpreted safety data to inform decision-making in clinical development
  • Managed adverse event reporting processes for multiple clinical trials
  • Developed and implemented risk evaluation and mitigation strategies
  • Provided safety oversight for a portfolio of investigational drugs
  • Contributed to the preparation of safety sections of regulatory submissions
  • Participated in safety review meetings with regulatory authorities
  • Mentored junior safety team members in pharmacovigilance and clinical studies best practices.

PV OPERATIONAL EXCELLENCE PROJECT MANAGER

Sanofi
07.2004 - 08.2018
  • Led cross-functional teams in implementing continuous improvement initiatives to drive productivity and reduce costs
  • Developed and executed project plans to streamline operations and optimize resources
  • Collaborated with stakeholders to identify and implement best practices for process improvement
  • Analyzed data to identify opportunities for improvement and implemented solutions to drive results
  • Developed and delivered training programs for employees to enhance knowledge and skills
  • Developed and implemented LEAN processes to streamline operations and increase productivity
  • Collaborated with stakeholders to identify and address key areas for operational improvement
  • Performed root cause analysis and implemented corrective actions to drive operational excellence
  • Managed vendor relationships and performance to ensure quality and efficiency in operations
  • Facilitated training sessions on operational best practices and process improvement methodologies
  • Led cross-functional teams in implementing safety pharmacovigilance processes and procedures
  • Managed and reviewed pharmacovigilance activities and ensured compliance with regulatory requirements
  • Developed and maintained safety databases to track adverse event reports and signal detection
  • Participated in safety surveillance activities and contributed to risk management plans
  • Collaborated with regulatory agencies and participated in audits and inspections
  • Conducted safety data analysis and prepared safety reports for internal and external stakeholders
  • Facilitated safety training sessions for internal staff and external partners.

CRITICAL CARE NURSE

Somerset Medical Center
04.1990 - 07.2004
  • Managed critical care patients in a fast-paced hospital setting
  • Collaborated with interdisciplinary team to provide high quality patient care
  • Utilized critical thinking skills to make quick decisions in emergency situations
  • Provided emotional support and education to families of critically ill patients
  • Documented patient assessments, interventions, and outcomes accurately
  • Participated in continuous education and training to stay current with best practices in critical care nursing
  • Assessed and monitored vital signs in critically ill patients
  • Provided direct patient care and support in ICU setting
  • Managed ventilators and other critical care equipment
  • Collaborated with interdisciplinary team to optimize patient outcomes
  • Monitored and interpreted patient vital signs and responses to treatment
  • Assessed and prioritized patient needs in high-stress environments
  • Facilitated smooth transitions of care during shift changes
  • Maintained accurate documentation of patient care activities and changes.

Education

MASTERS OF SCIENCE IN BIOSCIENCE REGULATORY AFFAIRS - Food And Drug Regulations

Johns Hopkins University
05.2014

CRITICAL CARE CERTIFIED NURSE -

American Nurses Association Credentialing Center
06.1994

CERTIFICATE IN COMMUNITY HEALTH NURSING, POST GRADUATE STUDY - Nursing

University of The Philippines
03.1990

BACHELOR OF SCIENCE IN NURSING NURSE MIDWIFERY PROGRAM - Nursing

Cebu State College -Southern Island Hospital College of Nursing
03.1979

Skills

  • Risk assessment
  • Safety monitoring
  • Adverse event reporting
  • Regulatory compliance
  • Team leadership
  • Critical thinking
  • Problem solving
  • Communication
  • Project management
  • Quality assurance
  • Motivating Teams
  • Influencing Others
  • Continuous improvements
  • Coaching abilities
  • Process Improvement
  • Visionary Thinking

Timeline

SENIOR CLINICAL SAFETY LEADER

Sanofi
10.2018 - 04.2024

PV OPERATIONAL EXCELLENCE PROJECT MANAGER

Sanofi
07.2004 - 08.2018

CRITICAL CARE NURSE

Somerset Medical Center
04.1990 - 07.2004

MASTERS OF SCIENCE IN BIOSCIENCE REGULATORY AFFAIRS - Food And Drug Regulations

Johns Hopkins University

CRITICAL CARE CERTIFIED NURSE -

American Nurses Association Credentialing Center

CERTIFICATE IN COMMUNITY HEALTH NURSING, POST GRADUATE STUDY - Nursing

University of The Philippines

BACHELOR OF SCIENCE IN NURSING NURSE MIDWIFERY PROGRAM - Nursing

Cebu State College -Southern Island Hospital College of Nursing

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