Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Microsoft Excel
- Microsoft Office
12d
Adult Learning Tutors - Surreywide
Surrey County Council —Guildford
- £26.26 - £30.57 an hour
- Part-time
- Spanish
- English
- Microsoft Office
- Annual leave
- Language training provided
Software Development Specialist
Vodafone —Newbury
- Full-time
- Computer Science
- Engineering
- SQL
- Annual leave
IP Design Lead
NSC Global —Reading
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
Applied AI Engineer – Prompting & Evaluation
KERRIDGE COMMERCIAL SYSTEMS CORP —Hungerford
- Full-time
- ERP systems
- Master's degree
- APIs
Quick apply
Accounts Payable Specialist (12 Months FTC)
OrganOx —Oxford
- Microsoft Excel
- Analysis skills
- Organisational skills
Quick apply
9d
Head of Engineering (Hybrid)
Automation Consultants Ltd —Reading
- £110,000 - £120,000 a year
- Hybrid work
- Management
- Computer Science
- AWS
- Annual leave
- Flexible schedule
Senior Finance Workday Reporting Specialist (Fixed Term)
SNG (Sovereign Network Group) —Basingstoke
- £70,000 - £85,000 a year
- Full-time
- SQL
- Analysis skills
- Travel
Optimisation Engineer
Stellar Entertainment Software Ltd —Guildford
- Full-time
- Hybrid work
- C++
- Employee assistance programme
Quick apply
9d
Residential Development Legal Director or Senior Associate
Gateley —Reading
- Annual leave
- Employee assistance programme
Senior Clinical Coder
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £32,073 - £39,043 a year
- Full-time
- Hybrid work
- In-person
11d
Information Security & Data Protection Manager
The Focusrite Group —High Wycombe
- £60,000 - £85,000 a year
- Full-time
- Hybrid work
- IT
- Life insurance
Quick apply
Embedded C Software Senior Engineer
Siemens Healthineers —Oxford
- Full-time
- Hybrid work
- Azure
- IT
- Communication skills
- Annual leave
23h
Systems Engineer
Stellar Entertainment Software Ltd —Guildford
- Full-time
- Hybrid work
- C++
- Employee assistance programme
Quick apply
9d
Site Set Up Associate
Gateley —Guildford
- IT
- Communication skills
- Annual leave
- Employee assistance programme
11d
Senior Systems Engineer
Stellar Entertainment Software Ltd —Guildford
- Full-time
- Hybrid work
- C++
- Employee assistance programme
Quick apply
9d
Senior Applied AI Engineer – Prompting & Evaluation
KERRIDGE COMMERCIAL SYSTEMS CORP —Hungerford
- Full-time
- ERP systems
- Master's degree
- Travel
Quick apply
Dailies Engineer, Picture Shop - Pinewood Studios
Streamland Media LLC —Iver Heath
- Weekend availability
- Maintenance
- Scripting
- Linux
Quick apply
Principal Consultant, Data Science, Research & Evidence Practice
Oxford Policy Management Limited —Oxford
- Hybrid work
- Management
- Doctoral degree
- English
- Annual leave
- Employee assistance programme
P2P Admin Support
Norgine —Uxbridge
- Full-time
- Hybrid work
- ERP systems
- Communication skills
Quick apply
4d

I want to receive the latest job alerts for coding specialist in reading, eng

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Sr. Drug Safety Specialist

GE HEALTHCARE -
Chalfont Saint Giles

Apply Now

Job details

12 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

coding specialist jobs in reading, eng

Sr. Drug Safety Specialist

Adult Learning Tutors - Surreywide

Software Development Specialist

IP Design Lead

Applied AI Engineer – Prompting & Evaluation

Accounts Payable Specialist (12 Months FTC)

Head of Engineering (Hybrid)

Senior Finance Workday Reporting Specialist (Fixed Term)

Optimisation Engineer

Residential Development Legal Director or Senior Associate

Senior Clinical Coder

Information Security & Data Protection Manager

Embedded C Software Senior Engineer

Systems Engineer

Site Set Up Associate

Senior Systems Engineer

Senior Applied AI Engineer – Prompting & Evaluation

Dailies Engineer, Picture Shop - Pinewood Studios

Principal Consultant, Data Science, Research & Evidence Practice

P2P Admin Support

I want to receive the latest job alerts for coding specialist in reading, eng

Explore jobs in more locations

Job Description Summary

Job Description

Additional Information

Jobseeker tools

Employer Tools

Browse

Stay Connected