Associate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance
About the position
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: We are seeking a skilled and experienced Associate Director (AD) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The AD GPS Quality and Compliance is responsible for the oversight and execution of the pharmacovigilance quality management system (PV-QMS) within the organization. This role ensures the safety of patients and the overall positive benefit-risk of RevMed pharmaceutical products by driving compliance with global pharmacovigilance regulations and fostering a culture of safety and vigilance. The responsibilities of this role include oversight of the PV-QMS , PV training, PV controlled documentation, inspection and audit management, ensuring inspection readiness, Corrective Action Preventive Action (CAPA) management, Quality Assurance (QA), and maintenance of Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP) in partnership with GPS management, QA, and staff. The AD of GPS Quality and Compliance will help to develop and implement the pharmacovigilance system in support of Revolution Medicine’s research and development and marketed products. The successful candidate will have innate management and organization skills, technical expertise in the field, and experience in organizing and overseeing pharmacovigilance quality, compliance, and training. As an AD, you will work closely with the GPS management team to develop and build out the PV-QMS as an important component of a fully compliant pharmacovigilance system; you will be responsible for supporting GCP/ICH quality leadership, strategic development of quality initiatives and support a quality focused culture in the execution of the PV-QMS. This critical role will require strategic thinking, expert knowledge of global PV regulations (i.e., GCP, GVP), the ability to influence and communicate ideas effectively, results orientation, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.
Responsibilities
• In cooperation with the GPS leadership team, co-develop and implement the global pharmacovigilance quality management system strategy in alignment with the company’s mission and objectives
• Develop and implement a PV training strategy that ensures compliance and ensures high quality and consistent performance.
• Coach GPS staff ensuring high quality compliance support following best practices, global regulations, and internal requirements.
• Support the management of the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in quality and compliance activities.
• Author and contribute to the preparation of controlled documentation required by health authorities for management of the QMS.
• Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate to ensure a globally compliant QMS.
• Collaborate to create robust processes to maintain compliance with safety requirements related to safety science processes.
• Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable.
• Support GPS management in ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements.
• Manage all inspections that include PV and ensure completion and tracking of CAPAs.
• Foster a culture of safety, compliance, and continuous improvement within the pharmacovigilance function and broadly across the organization.
• Ensure compliance with global pharmacovigilance regulations and standards, including FDA, EMA, PMDA, ICH, and other relevant regulatory bodies.
• Support the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections.
• Support the development and maintenance of a pharmacovigilance quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control.
• Partner with pharmacovigilance systems personnel in the development and implementation of advanced safety data analytics in support the PV-QMS.
• Contribute to a high-performing global pharmacovigilance team.
• Promote continuous professional development and ensure the team is equipped with the latest knowledge and skills in pharmacovigilance.
• Provide regular updates to senior leadership on the status of pharmacovigilance system effectiveness, and regulatory compliance.
• Ensure clear and effective communication of safety information to internal and external stakeholders.
Requirements
• RN or Bachelor’s degree in biological sciences or health related field required.
• Minimum of 7+ years of experience in pharmacovigilance or related field within the pharmaceutical or biotechnology industry.
• Minimum of 4+ years of project management experience; willingness to help others, and ability to deal with ambiguity.
• Proven track record of accomplishments in global pharmacovigilance environments.
• Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA).
• In-depth knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH, GxP)
• Strong analytical and strategic thinking, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company.
• Demonstrated technical expertise in QA/QC.
• Outstanding emotional intelligence.
• Proven ability to work collaboratively.
Nice-to-haves
• Advanced degree in Pharmacy, or a related field (PharmD, PhD: preferred).
• Experience with development of PV-QMS and key operating metrics enabling demonstration of operational control.
• Demonstrated ability to manage complex projects and work effectively in a matrixed organization.
• Proficiency in managing regulatory inspections and interactions.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Excellent influence and collaboration/teamwork capabilities.
Apply Now
Apply Now
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: We are seeking a skilled and experienced Associate Director (AD) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The AD GPS Quality and Compliance is responsible for the oversight and execution of the pharmacovigilance quality management system (PV-QMS) within the organization. This role ensures the safety of patients and the overall positive benefit-risk of RevMed pharmaceutical products by driving compliance with global pharmacovigilance regulations and fostering a culture of safety and vigilance. The responsibilities of this role include oversight of the PV-QMS , PV training, PV controlled documentation, inspection and audit management, ensuring inspection readiness, Corrective Action Preventive Action (CAPA) management, Quality Assurance (QA), and maintenance of Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP) in partnership with GPS management, QA, and staff. The AD of GPS Quality and Compliance will help to develop and implement the pharmacovigilance system in support of Revolution Medicine’s research and development and marketed products. The successful candidate will have innate management and organization skills, technical expertise in the field, and experience in organizing and overseeing pharmacovigilance quality, compliance, and training. As an AD, you will work closely with the GPS management team to develop and build out the PV-QMS as an important component of a fully compliant pharmacovigilance system; you will be responsible for supporting GCP/ICH quality leadership, strategic development of quality initiatives and support a quality focused culture in the execution of the PV-QMS. This critical role will require strategic thinking, expert knowledge of global PV regulations (i.e., GCP, GVP), the ability to influence and communicate ideas effectively, results orientation, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.
Responsibilities
• In cooperation with the GPS leadership team, co-develop and implement the global pharmacovigilance quality management system strategy in alignment with the company’s mission and objectives
• Develop and implement a PV training strategy that ensures compliance and ensures high quality and consistent performance.
• Coach GPS staff ensuring high quality compliance support following best practices, global regulations, and internal requirements.
• Support the management of the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in quality and compliance activities.
• Author and contribute to the preparation of controlled documentation required by health authorities for management of the QMS.
• Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate to ensure a globally compliant QMS.
• Collaborate to create robust processes to maintain compliance with safety requirements related to safety science processes.
• Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable.
• Support GPS management in ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements.
• Manage all inspections that include PV and ensure completion and tracking of CAPAs.
• Foster a culture of safety, compliance, and continuous improvement within the pharmacovigilance function and broadly across the organization.
• Ensure compliance with global pharmacovigilance regulations and standards, including FDA, EMA, PMDA, ICH, and other relevant regulatory bodies.
• Support the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections.
• Support the development and maintenance of a pharmacovigilance quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control.
• Partner with pharmacovigilance systems personnel in the development and implementation of advanced safety data analytics in support the PV-QMS.
• Contribute to a high-performing global pharmacovigilance team.
• Promote continuous professional development and ensure the team is equipped with the latest knowledge and skills in pharmacovigilance.
• Provide regular updates to senior leadership on the status of pharmacovigilance system effectiveness, and regulatory compliance.
• Ensure clear and effective communication of safety information to internal and external stakeholders.
Requirements
• RN or Bachelor’s degree in biological sciences or health related field required.
• Minimum of 7+ years of experience in pharmacovigilance or related field within the pharmaceutical or biotechnology industry.
• Minimum of 4+ years of project management experience; willingness to help others, and ability to deal with ambiguity.
• Proven track record of accomplishments in global pharmacovigilance environments.
• Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA).
• In-depth knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH, GxP)
• Strong analytical and strategic thinking, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company.
• Demonstrated technical expertise in QA/QC.
• Outstanding emotional intelligence.
• Proven ability to work collaboratively.
Nice-to-haves
• Advanced degree in Pharmacy, or a related field (PharmD, PhD: preferred).
• Experience with development of PV-QMS and key operating metrics enabling demonstration of operational control.
• Demonstrated ability to manage complex projects and work effectively in a matrixed organization.
• Proficiency in managing regulatory inspections and interactions.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Excellent influence and collaboration/teamwork capabilities.
Apply Now
Apply Now