Director, medical safety scientist Work, Jobs in Sandy, Bdf (with Salaries)

Director, Medical Safety Scientist
Jazz Pharmaceuticals —Cambridge
- Remote
- Doctoral degree
- Windows
- Master's degree
- Annual leave
Medical Director, Medical Safety
Jazz Pharmaceuticals —Cambridge
- £113,600 - £170,400 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Group Head of L&D Academy
MBDA —Stevenage
- £75,000 - £90,000 a year
- Hybrid work
- English
- Travel
- Leadership
- Free parking
Senior Safety Scientist / Associate Director / Director
Roche —Welwyn
- Doctoral degree
- Master's degree
- Presentation skills
Head of Operations (National)
GRS Group —Houghton Regis
- Full-time
- Hybrid work
- ERP systems
- Construction experience
- Leadership
- Employee assistance programme
Quick apply
11d
Head of Insights
Dominos —Milton Keynes
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
- Flexible schedule
Head of Leadership and Management Training
Royal Papworth Hospital NHS Foundation Trust —Cambridge
- £57,528 - £64,750 a year
- Full-time
- Master's degree
- Presentation skills
- Team management
Divisional Director of Operations - Clinical Administration
Royal Papworth Hospital NHS Foundation Trust —Cambridge
- £79,504 - £91,609 a year
- Weekend availability
- Continuous improvement
- Travel
- Patient care
4d
Senior Director, Translational Genetics
GlaxoSmithKline —Stevenage
- £207,075 - £345,125 a year
- Full-time
- Management
- Doctoral degree
- Machine learning
- Annual leave
Clinical Application Specialist - Sectra Medical
Sectra AB —Stevenage
- Sales
- Customer service
- Engineering
4d
Senior Director / Director, Non-Clinical Safety Project Specialist
GlaxoSmithKline —Stevenage
- £224,400 - £374,000 a year
- Full-time
- Doctoral degree
- Mentoring
- Annual leave
11d
Head of Supported Housing
The Housing Network —Luton
- Up to £56,000 an hour
- Full-time
- Travel
- In-person
- Health & wellbeing programme
- Annual leave
Quick apply
3d
Head of Quality Assurance
The Bedford College Group —Bedford
- £47,972 - £62,099 a year
- Full-time
- Analysis skills
- Education
- Continuous improvement
- Annual leave
Director of Technology and Operations
FCDO Services —Hanslope
- £81,000 - £117,800 a year
- Full-time
- Computer Science
- Presentation skills
- IT
Director, Translational Science Lead
GlaxoSmithKline —Stevenage
- £178,200 - £297,000 a year
- Full-time
- Doctoral degree
- Business development
- Leadership
- Annual leave
Senior Director, Biostatistics
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Management
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Head Of Food Operations
Medirest —Trumpington
- £65,000 a year
- Full-time
- Continuous improvement
- Food service experience
- Organisational skills
BioAnalytical Scientist
Eurofins UK PSS —Milton Keynes
- Full-time
- Microsoft Excel
- Laboratory experience
- Microsoft Office
- Free parking
- Employee assistance programme
Quick apply
Associate Director, Portfolio Project Management
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- PMP
- Project management
- Organisational skills
- Annual leave
- Employee assistance programme
Quick apply
7d

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director, medical safety scientist jobs near sandy, bdf

Director, Medical Safety Scientist

Jazz Pharmaceuticals -
Cambridge

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Job details

Benefits

Annual leave

Qualifications

Doctoral degree
Windows
Master's degree
Presentation skills
Bachelor's degree
Surveillance

Full job description

Job Details

Req ID:

R011231

Locations:

Cambridge, Cambridgeshire, UK; London, UK; Philadelphia, PA - [Remote/Home-Based]

Category:

Research & Development

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.

Essential Functions

Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
Authors or provides guidance for the production of risk management plans (RMPs).
Provides strategic input into regulatory requests / responses.
Delivers clinical safety input into clinical development program.
Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing

Partners, as needed.

Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
Escalates issues / concerns to senior management in a timely and appropriate manner.
Mentors and trains junior members of the Medical Safety team.

Required Knowledge, Skills, and Abilities

Minimum Requirements

At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
Ability to independently search clinical safety and literature databases for relevant information.
Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
In-depth knowledge of medical and drug terminology, as well as the clinical development process.
Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.

Required/Preferred Education and Licenses

Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.

#LI-Remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings : https://careers.jazzpharma.com/benefits.html.

Apply Now

Refine Your Search

director, medical safety scientist jobs in sandy, bdf

Director, Medical Safety Scientist

Medical Director, Medical Safety

(Senior) Global Medical Director, Established Brands

Group Head of L&D Academy

Senior Safety Scientist / Associate Director / Director

Head of Operations (National)

Head of Insights

Head of Leadership and Management Training

Divisional Director of Operations - Clinical Administration

Senior Director, Translational Genetics

Clinical Application Specialist - Sectra Medical

Senior Director / Director, Non-Clinical Safety Project Specialist

Head of Supported Housing

Head of Quality Assurance

Director of Technology and Operations

Director, Translational Science Lead

Senior Director, Biostatistics

Head Of Food Operations

BioAnalytical Scientist

Associate Director, Portfolio Project Management

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