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Senior Director, Inflammation TA Global Safety Leader
4 months ago
Senior Director, Inflammation TA Global Safety Leader page is loaded Senior Director, Inflammation TA Global Safety Leader
Apply locations United Kingdom - Cambridge time type Full time posted on Posted 4 Days Ago job requisition id R0040513 For Current Gilead Employees and Contractors:
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Inflammation Therapeutic Area (TA) Global Safety Leader
The candidate should be able to effectively strategize and implement benefit-risk activities across the product lifecycle. The candidate will also provide input into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, and pharmacovigilance processes and projects. Serves on cross-functional Global Development Teams as the safety expert, go-to-person, for safety profile of assigned products
Ensures proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of assigned products
Conducts and/or oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle
Supports implementation of decisions from safety governances, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
Provides global strategic input to management of potential safety issues and mitigation of safety risks
Contributes to and/or oversees the preparation of aggregate safety reports, risk management plans (RMPs), and regulatory documents
Communicates to senior management key pharmacovigilance findings
Represents the Patient Safety at meetings with internal and external stakeholders
Ensures own work complies with established practices, policies and processes, and regulatory requirements
Education & Experience
MD / Pharm D or other advanced degree in clinical sciences with significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, or academic or subspeciality medicine. Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).
Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. When needed, ability to travel.
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). For Current Gilead Employees and Contractors:
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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