- Accountable for the successful oversight and completion of a broad spectrum of MSS activities and deliverables for one or more products, compounds or indications in the assigned TA, in compliance with established practices, policies and processes, and any regulatory or other requirements.
- Advises other functions on short- and long-range MSS strategies, plans, resources and tactics.
- Performs or otherwise oversees safety reviews of clinical trial protocols, Investigator's Brochures, clinical study reports, informed consent forms, and other study related documents.
- Authors and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
- 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 the signal evaluation process, including updates to core safety information, Investigator's Brochure and other key safety documents and deliverables.
- Contributes to and/or oversees MSS activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
- Participates on Global Patient Safety (GLPS) and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and MSS functional area support in PV audits and inspections.
- Provides matrix management and leadership to project teams.
- May serve as medical monitor for post-authorization safety studies.
- May have one or more direct reports.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Expert 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).
- Expert knowledge of all key functions involved in the various stages of drug development from early research through postmarketing.
- In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.
- Strong knowledge of statistical methods used in PV.
- Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
- Strong negotiation and conflict resolution skills.
- Strong coaching capabilities to mentor/develop staff.
- When needed, ability to travel.
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Patient Safety Partner
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Physical Health Patient Safety Specialist
1 week ago
Cambridgeshire and Peterborough NHS Foundation Trust Cambridge, United KingdomCPFT are expanding their patient safety and quality portfolio and have generated two very exciting roles: Mental Health Patient Safety Specialist and Physical Health Patient Safety Specialist. Both roles are dedicated to providing expert knowledge in Mental Health & Physical Heal ...
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Patient Safety
1 week ago
West Suffolk NHS Foundation Trust Bury St. Edmunds, United KingdomThe West Suffolk NHS Foundation Trust are looking for a keen and enthusiastic administrator who can provide high-quality efficient administrative support to their small and friendly Patient Safety and Quality Team. · The Team's function is to develop and maintain effective system ...
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Patient Safety
1 week ago
West Suffolk NHS Foundation Trust Bury St. Edmunds, United KingdomThe West Suffolk NHS Foundation Trust are looking for a keen and passionate administrator who can provide high-quality efficient administrative support to their small and friendly Patient Safety and Quality Team. The Team's function is to develop and maintain effective systems an ...
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Patient Safety
1 week ago
West Suffolk NHS Foundation Trust Bury St. Edmunds, United KingdomThe West Suffolk NHS Foundation Trust are looking for a keen and passionate administrator who can provide high-quality efficient administrative support to their small and friendly Patient Safety and Quality Team. The Teams function is to develop and maintain effective systems and ...
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Patient Safety
1 week ago
West Suffolk NHS Foundation Trust Bury St. Edmunds, United KingdomPlease see job description for full details. Communication and Team Working Work with the team to administrate and coordinate the activities required in implementing the Trusts Patient Safety and Quality Strategy. Assist the team in the coordination of the implementation of actio ...
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Patient Safety
1 week ago
West Suffolk NHS Foundation Trust Bury St. Edmunds, United KingdomPlease see job description for full details. Communication and Team Working To pro-actively promote among staff, awareness of the Patient Safety & Quality Team and its function within the Trust. Facilitate improved communication within the department and between other departments ...
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Patient Safety Administrator
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Patient Safety Specialist
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Patient Safety Partner
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Patient Safety Administrator
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Patient Safety Partner
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Patient Safety Specialist
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East of England Ambulance Service Trust Bedford, United KingdomThe Patient Safety Specialist provides compassionate and collaborative senior leadership, visibility and expert support to the Patient Safety work within the organisation. · This role supports the development of a Patient Safety culture and safety systems and requires sufficient ...
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Head of Patient Safety
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East of England Ambulance Service Trust Bedford, United KingdomThis is a secondment vacancy - for the financial year 2023/24 · We are looking for an experienced safety professional to lead our team through the next 12 months. · It is a time of transition in safety. We have an excellent team that are able to take up the challenge. Are you the ...
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Patient Safety and Experience Officer
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LloydsPharmacy Clinical Homecare Harlow, United Kingdom**About The Role**: · *** · **Part time - 30 hours per week** · **12 month Fixed Term Contract** · As a Patient Safety and Experience Officer you will support implementation of the current professional and governance frameworks for homecare providers. Working with the senior Gove ...
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Senior Director, Patient Safety
1 week ago
Gilead Sciences, Inc. Cambridge, Cambridgeshire, United KingdomSenior Director, Patient Safety - TA Safety Physician page is loaded Senior Director, Patient Safety - TA Safety Physician · Bewerben locations United Kingdom - Cambridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Contrac ...
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Senior Director, Patient Safety
1 week ago
Gilead Sciences, Inc. Cambridge, Cambridgeshire, United KingdomSenior Director, Patient Safety - TA Safety Physician page is loaded · Senior Director, Patient Safety - TA Safety Physician · Bewerben locations United Kingdom - Cambridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Con ...
Director, Patient Safety - Cambridge, United Kingdom - Gilead Sciences International, Ltd.
Description
Description
FUNCTION: Medical Safety Science (MSS) / Global Therapeutic Area (TA) Safety Scientists
POSITION OVERVIEW:
You will develop or oversee and ensure that strategic scientific input relative to safety is incorporated into product development and lifecycle management as well as perform or oversee other advanced MSS activities for one or more products in the assigned therapeutic area. You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to postmarketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of MSS into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects, and PV or other audits and inspections. You may be assigned responsibilities as the Global Safety Lead (GSL); acting as the expert, go-to person regarding the safety profile of a product/compound or group of products/compounds. You will play a lead role within MSS by contributing to the ongoing and continuous improvement and advancing capabilities of the function.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including extensive experience working in drug safety / PV or a related field.
Knowledge & Other Requirements
Equal Employment Opportunity (EEO)
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). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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