Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Microsoft Excel
- Microsoft Office
10d
Regional Health, Safety and Fire Risk Specialist (South)
PortmanDentex —London
- Full-time
- Hybrid work
- Hospitality
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- Organisational skills
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Health and Safety Specialist
Red Kite Community Housing —High Wycombe
- £61,915.56 a year
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Safety Specialist
BBC —London
- £54,000 - £57,000 a year
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Fortius —London
- Full-time
- Negotiation
Quick apply
10d
Service Manager
SHJ Medical & Lab Gas Specialists —Chesham
- £55,000 - £70,000 a year
- Full-time
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- ERP systems
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- In-person
- Health & wellbeing programme
- Employee discount
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4d
Head of Operations - Event Traffic & Crowd Management
The Last Mile —London
- £60,000 a year
- 12 hour shift
- Management
- Microsoft Office
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8d
Aviation Vetting Officer
Wilson James —Slough
- £32,000 - £34,000 a year
- Full-time
- Microsoft Office
- Administrative experience
- Travel
- Annual leave
- Employee discount
6d
Specialist Forestry Arb Manager
Ben Nicholson Tree Services Ltd —Guildford
- Up to £250 a day
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9d
Technical Support Specialist
Intelligent Imaging Innovations —London
- From £40,000 a year
- Engineering
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H Plus Care Ltd —Maidenhead
- £24,420 - £30,000 a year
- Full-time
- Schematics
- Customer service
- Maintenance
Quick apply
12d
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Vertex Pharmaceuticals —Paddington
- Full-time
- Travel
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Carefirst24 —Slough
- £17 - £18 an hour
- Part-time
- Driving
- In-person
- Care plans
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ATC Computer Transport & Logistics —Slough
- £40,000 - £45,000 a year
- Full-time
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- Computer literacy
- Microsoft Office
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Hospital Operating Theatre Stores and Supplies Manager
The Royal Buckinghamshire Hospital —Aylesbury
- From £40,000 a year
- Full-time
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- In-person
- Employee discount
- Referral programme
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11d
Health and Safety Officer Full Time
NG Tunnelling —Mitcham
- Up to £75,000 a year
- Full-time
- Microsoft Word
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5d
Transport Planner – Tipper Fleet
kane Haulage Ltd —St Albans
- £30,000 - £40,000 a year
- Full-time
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Avia Technique Limited —Wokingham
- £32,500 - £38,000 a year
- Full-time
- Microsoft Office
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5d
Safety & Compliance Maintenance Specialist
Kitt —London
- £36,500 - £46,000 a year
- Full-time
- Basic maths
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RW Armstrong Group —High Wycombe
- Full-time
- Management
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- Employee assistance programme
- Employee discount
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11d

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Sr. Drug Safety Specialist

GE HEALTHCARE -
Chalfont Saint Giles

Apply Now

Job details

10 days ago

Qualifications

Microsoft Word
Microsoft Excel
Microsoft Office
Root cause analysis

Full job description

Job Description Summary

Primarily responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. Additionally, as a more advanced case processor, responsible for activities that support training, compliance, regulation changes, and the shaping of process improvements.

Job Description

Essential Responsibilities

Receive, triage and process adverse events and medical device reports from all sources including post-marketing, clinical trials and published literature
Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
Identify missing or discrepant information and perform active case follow-up via verbal or written contact
Review expedited reports for submission to regulatory authorities and ethics committees
Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., Regulatory Affairs, Medical Affairs, Quality Assurance, clinical development teams, CROs, etc.)
Perform reconciliations between clinical, quality and PV databases
Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
Serve as pharmacovigilance resource and subject matter expert during inspections and audits
Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality
Provide oversight of clinical trials, requesting study configurations and developing study-specific job aids, as needed.
Oversee workflow management and case prioritization to maintain compliance with regulatory timelines
Provide Compliance group with root cause analysis and CAPA for late submissions
Troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience and Data Handling Conventions
Assist with writing and updating of SOPs and other guidance documents, in response to process improvements or changing regulations
Participate in database projects and user acceptance testing, as needed, providing insight from business / case processing perspective

Qualifications/Requirements

Extensive years in pharmaceutical/biotechnology industry with experience in Pharmacovigilance including clinical trials and post-marketing.
Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters.
Strong understanding of Safety Database functionality and business workflow to be able to perform root cause analyses and troubleshoot
Confidence in decision-making, taking into consideration data handling conventions, but also industry expectations and regulations
Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
Demonstrated ability to train and coach PV personnel
Demonstrated ability to manage own workload, prioritize, plan and organize assignments and work within strict timelines
Understanding of Microsoft Office applications, specifically Excel and Word

Desired Characteristics

Healthcare professionals with clinical experience preferred.
Experience with Argus preferred.
Demonstrated initiative, teamwork, and accountability.
Demonstrated ability to manage and independently drive projects to completion, in addition to overseeing day-to-day case processing needs.

Note:
To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information

Relocation Assistance Provided: No

Apply Now

Refine Your Search

safety specialist jobs in eton, brk

Sr. Drug Safety Specialist

Regional Health, Safety and Fire Risk Specialist (South)

Health and Safety Specialist

Safety Specialist

Quality and Patient Safety Specialist

Service Manager

Head of Operations - Event Traffic & Crowd Management

Aviation Vetting Officer

Specialist Forestry Arb Manager

Technical Support Specialist

Maintenance

Facilities Operations Senior Specialist

Paediatric Complex Care Assistant

Health & Safety Advisor

Hospital Operating Theatre Stores and Supplies Manager

Health and Safety Officer Full Time

Transport Planner – Tipper Fleet

Junior Quality Engineer

Safety & Compliance Maintenance Specialist

Site Manager

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