Head of Pharmacovigilance and Drug Safety

Head of Pharmacovigilance and Drug Safety page is loaded## Head of Pharmacovigilance and Drug Safety locations:
Cambridge, MAtime type:
Full time posted on:
Posted Todayjob requisition :
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 Gates The 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…