Head of Pharmacovigilance and Drug Safety
Bill & Melinda Gates Foundation, Cambridge, Massachusetts, us, 02140
Head of Pharmacovigilance and Drug Safety page is loaded## Head of Pharmacovigilance and Drug Safetylocations:
Cambridge, MAtime type:
Full timeposted on:
Posted Todayjob requisition id:
B021399*“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”*-Bill GatesThe Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute.
Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration.
The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions.
The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.The Institute is based on five core “mantras” that are embedded within the organization and its people:* ***Urgency****: Execute with excellence to maximize impact.** ***Collaboration****: Establish empowered teams to drive our bottom line: lives saved.** ***Innovation***: *Build on the known, uncover the new, achieve the unprecedented.** ***Rigor****:* *Drive the science, focus on the details, and execute with the highest quality.** ***Courage****: Dare to confront the world’s most significant global health challenges.*Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.As a wholly owned subsidiary and separate legal entity of the Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.The Institute leverages dedicated vendor partnerships and consultant staff to ensure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.The Institute offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA area.
Remote arrangements may be available for this role subject to all legal and logistical requirements that may vary by remote location.**THE POSITION**Reporting to the Chief Medical Officer, the **Head of** **Pharmacovigilance and Drug Safety** serves as the enterprise safety strategy owner, responsible for designing, governing, and optimizing an end‑to‑end global pharmacovigilance system. This role provides strategic leadership for all Gates MRI clinical programs by overseeing enterprise safety governance, safety risk management, safety data integration across partners, medical oversight of case processing, cross portfolio signal detection and benefit - risk evaluation in collaboration with the PV Operations Functional Service Provider (FSP).
It will liaise with commercialization partners to guide risk management plan development and post-market approval safety surveillance systems and processes for Gates MRI assets.This role will oversee patient/participant safety in collaboration with clinical development leaders across programs including contributions to relevant clinical trial design elements, and ensure the timeliness and integrity of safety reporting for the portfolio of clinical trials that are conducted by Gates MRI in diverse environments, from experimental medicine and controlled human infection trials to large, multinational Phase 2b and Phase 3 prevention and treatment trials in low- and middle-income settingsThe successful candidate will be an experienced hands-on leader that will serve as a medical lead and a drug safety subject matter and pharmacovigilance process expert. They will be responsible for ensuring that safety oversight for clinical trials in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines and partner requirements.The Gates MRI works in an outsourced model.
To evolve and maintain our PV and DS strategy, this role will partner closely with our designated FSP primarily, leveraging other resource models in times of demonstrable need.
It will also maintain development and compliance accountability supported in execution by our FSP partner on a day-to-day basis.In addition, the person will work collaboratively with other leaders within the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.This role will oversee the development and execution of safety data exchange agreements with each partner and act as the medical safety lead in ongoing collaborations to ensure optimal relationship management. From a vendor management perspective, it will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinicians.This position will aid the CMO and the Head of Development Operations to ensure rigorous and robust processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities are in place and operating optimally. It will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinical development leaders.**Responsibilities*** Oversee the Safety Review Committee process, which has primary responsibility for assessing emerging safety signals from ongoing clinical trials and provide input into safety data monitoring plans.* Provide pharmacovigilance input for trial protocols, safety monitoring plans and other clinical study-relevant documents, review safety tables, figures, and listings from clinical trials, and author/supervise the preparation of safety update reports and safety contents for regulatory filings including new drug applications and marketing authorization applications.* Own the global safety strategy and governance framework for all Gates MRI programs, ensuring integrated, risk-based PV oversight across internal teams, FSP partners, external partners, and CROs, as applicable.* Oversee and direct medical review of all safety cases across programs, including MD adjudication of validity, completeness, causality, expectedness, and regulatory classification, delegating operational execution to FSP teams while maintaining final medical accountability.* Oversee the development of all safety regulatory deliverables—including DSURs, safety narratives, Module 2.5/2.7.4 components of global submissions, SAHPRA periodic reports, and safety contributions to NDA/MAA filings—ensuring alignment across partners, FSP, and internal development leads.* Direct cross portfolio safety surveillance, including daily SAE review (via FSP), signal detection #J-18808-Ljbffr
Cambridge, MAtime type:
Full timeposted on:
Posted Todayjob requisition id:
B021399*“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”*-Bill GatesThe Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute.
Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration.
The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions.
The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.The Institute is based on five core “mantras” that are embedded within the organization and its people:* ***Urgency****: Execute with excellence to maximize impact.** ***Collaboration****: Establish empowered teams to drive our bottom line: lives saved.** ***Innovation***: *Build on the known, uncover the new, achieve the unprecedented.** ***Rigor****:* *Drive the science, focus on the details, and execute with the highest quality.** ***Courage****: Dare to confront the world’s most significant global health challenges.*Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.As a wholly owned subsidiary and separate legal entity of the Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.The Institute leverages dedicated vendor partnerships and consultant staff to ensure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.The Institute offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA area.
Remote arrangements may be available for this role subject to all legal and logistical requirements that may vary by remote location.**THE POSITION**Reporting to the Chief Medical Officer, the **Head of** **Pharmacovigilance and Drug Safety** serves as the enterprise safety strategy owner, responsible for designing, governing, and optimizing an end‑to‑end global pharmacovigilance system. This role provides strategic leadership for all Gates MRI clinical programs by overseeing enterprise safety governance, safety risk management, safety data integration across partners, medical oversight of case processing, cross portfolio signal detection and benefit - risk evaluation in collaboration with the PV Operations Functional Service Provider (FSP).
It will liaise with commercialization partners to guide risk management plan development and post-market approval safety surveillance systems and processes for Gates MRI assets.This role will oversee patient/participant safety in collaboration with clinical development leaders across programs including contributions to relevant clinical trial design elements, and ensure the timeliness and integrity of safety reporting for the portfolio of clinical trials that are conducted by Gates MRI in diverse environments, from experimental medicine and controlled human infection trials to large, multinational Phase 2b and Phase 3 prevention and treatment trials in low- and middle-income settingsThe successful candidate will be an experienced hands-on leader that will serve as a medical lead and a drug safety subject matter and pharmacovigilance process expert. They will be responsible for ensuring that safety oversight for clinical trials in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines and partner requirements.The Gates MRI works in an outsourced model.
To evolve and maintain our PV and DS strategy, this role will partner closely with our designated FSP primarily, leveraging other resource models in times of demonstrable need.
It will also maintain development and compliance accountability supported in execution by our FSP partner on a day-to-day basis.In addition, the person will work collaboratively with other leaders within the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.This role will oversee the development and execution of safety data exchange agreements with each partner and act as the medical safety lead in ongoing collaborations to ensure optimal relationship management. From a vendor management perspective, it will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinicians.This position will aid the CMO and the Head of Development Operations to ensure rigorous and robust processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities are in place and operating optimally. It will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinical development leaders.**Responsibilities*** Oversee the Safety Review Committee process, which has primary responsibility for assessing emerging safety signals from ongoing clinical trials and provide input into safety data monitoring plans.* Provide pharmacovigilance input for trial protocols, safety monitoring plans and other clinical study-relevant documents, review safety tables, figures, and listings from clinical trials, and author/supervise the preparation of safety update reports and safety contents for regulatory filings including new drug applications and marketing authorization applications.* Own the global safety strategy and governance framework for all Gates MRI programs, ensuring integrated, risk-based PV oversight across internal teams, FSP partners, external partners, and CROs, as applicable.* Oversee and direct medical review of all safety cases across programs, including MD adjudication of validity, completeness, causality, expectedness, and regulatory classification, delegating operational execution to FSP teams while maintaining final medical accountability.* Oversee the development of all safety regulatory deliverables—including DSURs, safety narratives, Module 2.5/2.7.4 components of global submissions, SAHPRA periodic reports, and safety contributions to NDA/MAA filings—ensuring alignment across partners, FSP, and internal development leads.* Direct cross portfolio safety surveillance, including daily SAE review (via FSP), signal detection #J-18808-Ljbffr