Vor Bio
Overview
The Vice President of Pharmacovigilance is a key leadership role responsible for overseeing the safety monitoring of pharmaceutical products throughout their lifecycle. This position ensures compliance with global regulatory requirements, manages risk assessment activities, and leads a team dedicated to safeguarding patient safety. The role collaborates cross-functionally with clinical, regulatory, and commercial teams to support product development and post-marketing surveillance. Responsibilities
Strategic Leadership
Develop and implement the overall pharmacovigilance strategy for the organization. Provide expert guidance on safety risk management and regulatory compliance. Represent the pharmacovigilance function in executive meetings and cross-functional projects.
Safety Surveillance & Risk Management
Oversee the collection, evaluation, and reporting of adverse events for all products. Lead signal detection, risk assessment, and mitigation activities. Ensure timely submission of safety reports to regulatory authorities.
Regulatory Compliance
Maintain up-to-date knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH). Ensure all pharmacovigilance activities meet international standards and company policies. Prepare for and participate in regulatory inspections and audits.
Team Leadership & Development
Manage, mentor, and develop a high-performing pharmacovigilance team. Allocate resources effectively to meet project and compliance deadlines. Foster a culture of continuous improvement and professional growth.
Cross-Functional Collaboration
Work closely with clinical development, medical affairs, regulatory affairs, and commercial teams. Provide safety input for clinical trial protocols, informed consent forms, and product labeling. Support due diligence and integration activities for business development initiatives.
Qualifications
Education: Advanced degree in pharmacy, medicine, life sciences, or a related field (e.g., PharmD, MD, PhD). Experience: 15+ years in pharmacovigilance, with at least 5 years in a leadership role. Expertise: In-depth knowledge of global pharmacovigilance regulations and best practices. Skills: Strong leadership, communication, and organizational skills; ability to manage complex projects and teams. Certifications: Certification in pharmacovigilance or drug safety (preferred). Key Competencies
Analytical Thinking: Ability to interpret complex safety data and make informed decisions. Attention to Detail: Ensures accuracy in safety reporting and documentation. Collaboration: Builds effective relationships across departments and with external partners. Adaptability: Responds effectively to changing regulatory landscapes and business needs. Ethical Judgment: Maintains the highest standards of integrity and patient safety. Benefits & Equality
At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.
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The Vice President of Pharmacovigilance is a key leadership role responsible for overseeing the safety monitoring of pharmaceutical products throughout their lifecycle. This position ensures compliance with global regulatory requirements, manages risk assessment activities, and leads a team dedicated to safeguarding patient safety. The role collaborates cross-functionally with clinical, regulatory, and commercial teams to support product development and post-marketing surveillance. Responsibilities
Strategic Leadership
Develop and implement the overall pharmacovigilance strategy for the organization. Provide expert guidance on safety risk management and regulatory compliance. Represent the pharmacovigilance function in executive meetings and cross-functional projects.
Safety Surveillance & Risk Management
Oversee the collection, evaluation, and reporting of adverse events for all products. Lead signal detection, risk assessment, and mitigation activities. Ensure timely submission of safety reports to regulatory authorities.
Regulatory Compliance
Maintain up-to-date knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH). Ensure all pharmacovigilance activities meet international standards and company policies. Prepare for and participate in regulatory inspections and audits.
Team Leadership & Development
Manage, mentor, and develop a high-performing pharmacovigilance team. Allocate resources effectively to meet project and compliance deadlines. Foster a culture of continuous improvement and professional growth.
Cross-Functional Collaboration
Work closely with clinical development, medical affairs, regulatory affairs, and commercial teams. Provide safety input for clinical trial protocols, informed consent forms, and product labeling. Support due diligence and integration activities for business development initiatives.
Qualifications
Education: Advanced degree in pharmacy, medicine, life sciences, or a related field (e.g., PharmD, MD, PhD). Experience: 15+ years in pharmacovigilance, with at least 5 years in a leadership role. Expertise: In-depth knowledge of global pharmacovigilance regulations and best practices. Skills: Strong leadership, communication, and organizational skills; ability to manage complex projects and teams. Certifications: Certification in pharmacovigilance or drug safety (preferred). Key Competencies
Analytical Thinking: Ability to interpret complex safety data and make informed decisions. Attention to Detail: Ensures accuracy in safety reporting and documentation. Collaboration: Builds effective relationships across departments and with external partners. Adaptability: Responds effectively to changing regulatory landscapes and business needs. Ethical Judgment: Maintains the highest standards of integrity and patient safety. Benefits & Equality
At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.
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