Showing results for drug testing jobs

Search instead for jobs

Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Microsoft Excel
- Microsoft Office
12d
Occupational Health Technician
Latus Group —Oxford
- £30,600 a year
- Weekend availability
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Quick apply
6d
Prisoner Custody Officer
Serco Plc —Aylesbury
- £24,596 - £27,180 a year
- Full-time
- IT
- Communication skills
- Paid training
- Employee assistance programme
Assistant Driller – Ground Investigation
Topdrill Ltd —Milton Keynes
- From £29,741.40 a year
- Weekend availability
- Bachelor's degree
- Health & wellbeing programme
Quick apply
4d
Detention Custody Officer
Mitie —Oxford
- £31,500 a year
- Overtime
- English
- Communication skills
Emergency Response Officer
Mitie —Oxford
- £15.16 an hour
- 12 hour shift
- IT
- Communication skills
- Employee discount
Analyst
Abbott Laboratories —Abingdon
- Full-time
- Laboratory experience
6d
Principal Scientist, Bioanalytical & Molecular Assays
Moderna, Inc. —Oxford
- Full-time
- Doctoral degree
- Master's degree
- Annual leave
13d
Planning Coordinator
M Group —Slough
- IT
- Communication skills
- Annual leave
- Employee assistance programme
BioAssay Scientist
Eurofins UK PSS —Slough
- Full-time
- Laboratory experience
- Microsoft Office
- Mentoring
- Free parking
- Employee assistance programme
Quick apply
Senior Research Associate, Clinical Biomarker Laboratory, Immunoassays
Moderna, Inc. —Oxford
- Overtime
- Microsoft Powerpoint
- Laboratory experience
- Master's degree
- Annual leave
11d
Senior Research Associate, Bioanalytical & Molecular Assays - Ligand Binding Assays
Moderna, Inc. —Oxford
- Full-time
- Data analysis skills
- Bachelor's degree
- Communication skills
- Annual leave
7d
Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based
Moderna, Inc. —Oxford
- Weekend availability
- Microsoft Powerpoint
- Doctoral degree
- Data analysis skills
- Annual leave
11d
Accounts Payable Accounts Assistant
Evotec —Abingdon
- Full-time
- Hybrid work
- ERP systems
- English
- Accounting
- Referral programme
Youth Escort & Custody Driver
Serco Plc —Buckingham
- £24,596 - £34,805 a year
- Overtime
- Driving
- IT
- Communication skills
- Paid training
- Employee assistance programme
Principal Research Associate, Clinical Biomarker Laboratory, Flow Cytometry
Moderna, Inc. —Oxford
- Weekend availability
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
13d
Detention Custody Manager
Mitie —Oxford
- £38,000 a year
- Overtime
- English
- Leadership
- Life insurance
Occupational Health Technician - Milton Keynes
Tetra Tech —Milton Keynes
- £26,000 - £30,000 a year
- Overtime
- Microsoft Office
- Driving
- Travel
Technician [Signalling Maintenance]
Network Rail —Milton Keynes
- £45,669 a year
- Weekend availability
- Maintenance
- IT
- Leadership
13d
Senior QA Product Specialist – 15 Months FTC
Kyowa Kirin International —Marlow
- £44,417 - £89,506 a year
- Travel
- Communication skills
Quick apply
12d

I want to receive the latest job alerts for drug testing in aylesbury, 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

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

drug testing jobs in aylesbury, bkm

Sr. Drug Safety Specialist

Occupational Health Technician

Prisoner Custody Officer

Assistant Driller – Ground Investigation

Detention Custody Officer

Emergency Response Officer

Analyst

Principal Scientist, Bioanalytical & Molecular Assays

Planning Coordinator

BioAssay Scientist

Senior Research Associate, Clinical Biomarker Laboratory, Immunoassays

Senior Research Associate, Bioanalytical & Molecular Assays - Ligand Binding Assays

Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

Accounts Payable Accounts Assistant

Youth Escort & Custody Driver

Principal Research Associate, Clinical Biomarker Laboratory, Flow Cytometry

Detention Custody Manager

Occupational Health Technician - Milton Keynes

Technician [Signalling Maintenance]

Senior QA Product Specialist – 15 Months FTC

I want to receive the latest job alerts for drug testing in aylesbury, bkm

Related Searches

Explore jobs in more locations

Job Description Summary

Job Description

Additional Information

Jobseeker tools

Employer Tools

Browse

Stay Connected