Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Microsoft Excel
- Microsoft Office
Birds of Prey Keeper / Falconer
Splendid Spa —Windsor
- £31,650 - £36,750 an hour
- Weekend availability
- Driving
- In-person
- Free parking
- Sick pay
Quick apply
13d
Animal Keeper - Humboldt Penguins
Splendid Spa —Windsor
- £31,750 - £36,750 a year
- Weekend availability
- Organisational skills
- In-person
- Free parking
- Sick pay
Quick apply
13d
Hospital Operating Theatre Stores and Supplies Manager
The Royal Buckinghamshire Hospital —Aylesbury
- From £40,000 a year
- Full-time
- Management
- Bachelor's degree
- In-person
- Employee discount
- Referral programme
Quick apply
Trainee Human Factors Health and Safety Specialist
UK Health Security Agency —London
- £41,983 - £52,113 a year
- Part-time
- Hybrid work
- Master's degree
- Presentation skills
- Bachelor's degree
Surgical Training Specialist
Smith & Nephew —Watford
- Full-time
- Hybrid work
- Laboratory experience
- No degree
- Communication skills
- Annual leave
- Employee discount
12d
Specialist, Sourcing - DC Operations
NTT Global Data Centers —Hemel Hempstead
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Business
HM Inspector of Railway Human Factors Specialist
Office of Rail and Road —London
- £58,827 - £64,237 a year
- Part-time
- Hybrid work
- Presentation skills
5d
Functional Skills Assessor
Animal Antiks —North Marston
- £28,000 - £30,000 an hour
- Full-time
- English
- Education
- First Aid Certification
- Free parking
- Health & wellbeing programme
Quick apply
7d
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
- Communication skills
- Free parking
- Annual leave
10d
Intelligence Research Officer
Thames Valley Police —Slough
- £35,241 a year
- Part-time
- Annual leave
- Employee discount
12d
Senior Event Health & Safety Advisor
HornerSalus Ltd —London
- Up to £55,000 a year
- Overtime
- English
- Bachelor's degree
- IT
- Flexitime
- Work from home
Quick apply
7d
HM Inspector of Railways Electrical Safety Specialist
Office of Rail and Road —London
- £58,827 - £64,237 a year
- Part-time
- Hybrid work
- Engineering
- Presentation skills
- Electrical Engineering
Delivery Manager
HM Courts & Tribunal Service —Watford
- £40,001 - £50,000 a year
- Part-time
- Hybrid work
- Presentation skills
- Travel
- Leadership
- Annual leave
- Employee discount
5d
Detective Constable Accelerated Entry Scheme - External Applicants (Inner London)
British Transport Police —London
- £32,472 - £50,256 a year
- No experience needed
- Classroom experience
- Communication skills
- Annual leave
- Employee discount
Quick apply
12d
Building Safety Consultant
4site Consulting Ltd —London
- £56,000 - £60,000 a year
- Full-time
- Hybrid work
- Travel
- Free parking
- Annual leave
Quick apply
11d
Logistics Specialist - Data Center , Logistics Specialist DC
Amazon Data Services UK Limited —Slough
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Flight Safety Performance Specialist
British Airways —Heathrow
- Full-time
- Analysis skills
- No degree
- Communication skills
13d
Lifecycle Project Manager
Serco Group —High Wycombe
- £60,000 - £65,000 a year
- Full-time
- Hybrid work
- Project management
- No degree
- Communication skills
- Employee assistance programme
Environment Protection Officer - Licensing
The Royal Borough of Kingston upon Thames —Kingston upon Thames
- £33,987 - £42,060 a year
- Full-time
- Hybrid work
- In-person
- Time management
- Annual leave
- Employee discount

I want to receive the latest job alerts for safety specialist in seer green, bkm

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

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 seer green, bkm

Sr. Drug Safety Specialist

Birds of Prey Keeper / Falconer

Animal Keeper - Humboldt Penguins

Hospital Operating Theatre Stores and Supplies Manager

Trainee Human Factors Health and Safety Specialist

Surgical Training Specialist

Specialist, Sourcing - DC Operations

HM Inspector of Railway Human Factors Specialist

Functional Skills Assessor

Level 7 Health & Care Intelligence Specialist Apprentice

Intelligence Research Officer

Senior Event Health & Safety Advisor

HM Inspector of Railways Electrical Safety Specialist

Delivery Manager

Detective Constable Accelerated Entry Scheme - External Applicants (Inner London)

Building Safety Consultant

Logistics Specialist - Data Center , Logistics Specialist DC

Flight Safety Performance Specialist

Lifecycle Project Manager

Environment Protection Officer - Licensing

I want to receive the latest job alerts for safety specialist in seer green, bkm

Related Searches

Explore jobs in more locations

Job Description Summary

Job Description

Additional Information

Jobseeker tools

Employer Tools

Browse

Stay Connected