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- Microsoft Excel
- Microsoft Office
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AWE —Reading
- From £36,340 a year
- Full-time
- Computer literacy
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1d
Specialist, Sourcing - DC Operations
NTT Global Data Centers —Hemel Hempstead
- Full-time
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- Bachelor's degree
- Travel
- Business
Level 7 Health & Care Intelligence Specialist Apprentice
Royal Borough of Windsor and Maidenhead —Maidenhead
- £39,526 - £43,613 a year
- Full-time
- Hybrid work
- Master's degree
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14d
Facilities Manager
NATIVE Communities —Woking
- £55,000 - £60,000 a year
- Full-time
- Microsoft Word
- Microsoft Outlook
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- Referral programme
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2d
APQP Specialist - 12m Inside IR35 Contractor
Safran Engineering Services UK Limited —Pitstone
- Engineering
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- Bachelor's degree
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Servicing & Multi Drop Delivery (Van Driver) - 4 days per week F/T role
Our Honest Foods —High Wycombe
- £28,000 - £30,000 a year
- Full-time
- Customer service
- Driving
- Organisational skills
- Annual leave
- Employee discount
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Field Operational Trainer
Lanes Group —Slough
- £45,000 a year
- Full-time
- Maintenance
- Travel
- Communication skills
Quick apply
Technical Provisioning & Support Specialist
Danescroft Solutions —London
- £25,000 - £30,000 a year
- Full-time
- Software troubleshooting
- Customer service
- IT
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8d
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The Royal Buckinghamshire Hospital —Aylesbury
- From £40,000 a year
- Full-time
- Management
- Bachelor's degree
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- Employee discount
- Referral programme
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SouthOxfordshireAndVale —Abingdon
- £52,892 - £58,923 a year
- Maintenance
- Project management
- Continuous improvement
- Flexible schedule
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LF&E Refrigerated Transport —High Wycombe
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2h
Product Specialist - South East
Accora —Watford
- Full-time
- Remote
- English
- Organisational skills
- IT
- Annual leave
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Intuitive Surgical —Reading
- Day shift
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- Anatomy knowledge
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Product Safety Europe Digital & IUCLID Lead
Syngenta Crop Protection —Bracknell
- Full-time
- Hybrid work
- No degree
- AI
- Leadership
- Life insurance
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Out of Hours Regional Team Manager
Lanes Group —Slough
- Weekend availability
- Microsoft Office
- Team management
- Phone etiquette
Quick apply
Controls and Assembly Technician
Newman Labelling Ltd —Hatfield
- £35,000 - £55,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Free parking
Quick apply
8d

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Sr. Drug Safety Specialist

GE HEALTHCARE -
Chalfont Saint Giles

Apply Now

Job details

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

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