Director, medical safety scientist Work, Jobs in Caxton, Cam (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
- £256,000 - £384,000 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
13d
Executive Medical Director, Clinical Development Lead - Oncology
GlaxoSmithKline —Stevenage
- £242,250 - £403,750 a year
- Full-time
- Hybrid work
- Doctoral degree
- In-person
- Leadership
- Annual leave
3d
Medical Director, UK and Ireland
Mundipharma —Cambridge
- Full-time
- English
- Leadership
Head of Curriculum - Health
Hart Learning Group —Stevenage
- Up to £67 an hour
- Full-time
- English
5d
Senior Director, Group Supply Chain
Faerch Group —Ely
Quick apply
10d
Group Head of L&D Academy
MBDA —Stevenage
- £75,000 - £90,000 a year
- Hybrid work
- English
- Travel
- Leadership
- Free parking
Head of Business Services
MBS Management & Business Solutions Ltd —Cambridge
- £4,800 - £7,200 a month
- Full-time
- Management
- Organisational skills
- In-person
- Health & wellbeing programme
Quick apply
5h
Transformation Director
M Group —Stevenage
- Leadership
- Annual leave
- Employee assistance programme
2d
Estates Director
hireful —Bedford
- £70,000 - £75,000 a year
- IT
- Communication skills
Quick apply
6d
Director, Clinical Safety Scientist (Radiopharmaceuticals)
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Leadership
- Communication skills
- Annual leave
- Employee assistance programme
Quick apply
Sr Dir Ops - Medical Communications
Thermo Fisher Scientific —Cambridge
- 8 hour shift
- Management
- Doctoral degree
- Leadership
Deputy Development Director
Fitzwilliam College —Cambridge
- Full-time
- Microsoft Office
- Master's degree
- Project management
- Free parking
- Annual leave
2d
Director, Translational Science Lead
GlaxoSmithKline —Stevenage
- £178,200 - £297,000 a year
- Full-time
- Doctoral degree
- Business development
- Leadership
- Annual leave
13d
Brand Director
Active Care Group —Newmarket
- Full-time
- Hybrid work
- Case management
- No degree
- Leadership
- Employee assistance programme
- Referral programme
Impact and Partnerships Director
Cambridge Hughes Hall —Cambridge
- £70,929 - £82,194 a year
- Full-time
2d
Head of Supporter Engagement
East Anglia's Children's Hospices —Cambridge
- £43,000 - £50,000 a year
- Part-time
- Hybrid work
- Travel
- Leadership
- Communication skills
9d
Director, Project Team Lead, Early Research
Flagship Pioneering, Inc. —Cambridge
- Doctoral degree
- Laboratory experience
- Master's degree
Head of Housing
Hundred Houses Society —Cambridge
- £62,218 a year
- Full-time
- Leadership
- Communication skills
- Negotiation
- Annual leave
- Employee assistance programme
12d

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Director, Medical Safety Scientist

Jazz Pharmaceuticals -
Cambridge

Apply Now

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 caxton, cam

Director, Medical Safety Scientist

Medical Director, Medical Safety

(Senior) Global Medical Director, Established Brands

Executive Medical Director, Clinical Development Lead - Oncology

Medical Director, UK and Ireland

Head of Curriculum - Health

Senior Director, Group Supply Chain

Group Head of L&D Academy

Head of Business Services

Transformation Director

Estates Director

Director, Clinical Safety Scientist (Radiopharmaceuticals)

Sr Dir Ops - Medical Communications

Deputy Development Director

Director, Translational Science Lead

Brand Director

Impact and Partnerships Director

Head of Supporter Engagement

Director, Project Team Lead, Early Research

Head of Housing

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