Drug safety Work, Jobs in England (with Salaries)

Drug Safety Associate II
Corbus Pharmaceuticals Inc —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Quick apply
9d
Laboratory Operations Assistant
Valink Therapeutics —London
- Laboratory experience
- Maintenance
- Bachelor's degree
10d
Trainee Train Driver - Blackpool
Northern Trains —Blackpool
- £27,870 - £67,104 a year
- Weekend availability
- Travel
- IT
- Communication skills
- Annual leave
- Employee assistance programme
8d
(Fixed Term) Laboratory Technician, Clinical Biomarker Laboratory, Immunoassay
Moderna, Inc. —Oxford
- Overtime
- Microsoft Powerpoint
- Laboratory experience
- Master's degree
- Annual leave
Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Microsoft Excel
- Microsoft Office
BAS: Intelligence Analyst
Ministry of Justice —Exeter
- £30,001 - £40,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- English
- Annual leave
10d
Clinical Research Coordinator -Wolverhampton, UK
IQVIA —Wolverhampton
- Part-time
- Microsoft Access
- Microsoft Outlook
- Windows
4d
Aircraft Refueller
Menzies Aviation —London
- Full-time
- Leadership
- Communication skills
10d
Laboratory Scientist – Genetics
AlphaBiolabs —Warrington
- £24,784 a year
- Microsoft Excel
- Microsoft Outlook
- Laboratory experience
- Free parking
- Employee assistance programme
Technician [Off Track]
Network Rail —Romford
- £38,482 a year
- Full-time
- Annual leave
- Employee discount
10d
Junior Metallurgist
AMETEK, Inc. —Plymouth
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Sexual Health Adviser
Chelsea and Westminster Hospital NHS Foundation Trust —London
- £47,951 - £56,863 a year
- Weekend availability
- Psychology
- Organisational skills
- Communication skills
11d
Research Assistant/ Associate in Translational Cancer Research
Newcastle University —Newcastle upon Tyne
- £33,951 - £35,608 a year
- Full-time
- Doctoral degree
- Laboratory experience
- University
9d
Laboratory Assistant
University of Oxford —Oxford
- £28,437 - £34,732 a year
- Full-time
- Laboratory experience
- Maintenance
- Microsoft Office
9d
Medicines Management Technician
eMed —London
- £32,000 a year
- Remote
- GP surgery experience
- Data analysis skills
- IT
- Employee assistance programme
- Life insurance
Quick apply
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
14d
Detention Custody Officer - Heathrow AP
Mitie —Hounslow
- £32,635 a year
- Full-time
- No experience needed
- Driving
- Communication skills
- Paid training
Study Physician - Bank, Full-Time
hVIVO Services Limited —London
- English
7d
Enterprise Account Executive - Life Sciences
Anthropic —London
- £280,000 - £330,000 a year
- Hybrid work
- Bachelor's degree
- AI
- Communication skills
- Flexible schedule
14d
Gambling Wellbeing Practitioner
Gordon Moody —Redditch
- £26,967 - £31,597 a year
- Weekend availability
- Cooking
- IT
- In-person

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Drug Safety Associate II

Corbus Pharmaceuticals Inc -
London

Quick apply

Job details

9 days ago

Qualifications

Microsoft Powerpoint
Microsoft Word
Nursing
Microsoft Excel
Oracle
Doctoral degree
Microsoft Office
Master's degree
Bachelor's degree
Technical writing
ESG
FDA regulations
Nursing

Full job description

Description:

The Drug Safety Associate II/Senior Drug Safety Associate is the senior technical contributor anchoring Corbus Pharmaceuticals' in-house PV function. In addition to managing complex ICSRs and SUSARs, this individual will assist with case processing, QC of cases, SMP authoring, generate listings upon request, assist with aggregate report preparation (DSUR/PBRER), Literature search, and mentor the junior associate. The ideal candidate brings deep Veeva Vault Safety expertise and thorough command of FDA and EMA PV regulations.

KEY RESPONSIBILITIES

Complex Case Management:

Independently process and quality-review complex ICSRs, SUSARs, and cases of special interest across all Corbus programs.
Lead SUSAR causality assessment and blind review with the Medical Monitor; coordinate unblinding decisions per protocol.
Perform and document expectedness assessment against the Reference Safety Information (IB/SmPC);
Oversee 7- and 15-day expedited submission workflow; act as backup submitter and regulatory gateway owner.
QC case quality and narratives prepared by the junior associate; provide coaching and sign-off.

Aggregate Reporting & Signal Detection:

Maintain Safety meeting minutes, documentation for Signal detection and Safety trackers
Generate ad hoc line listings and cumulative summaries for regulatory queries using Vault Safety analytics.

Regulatory Collaboration & Audit Readiness:

Regular Safety SOP review, assist in drafting and maintaining the Pharmacovigilance System Master File (PSMF) and procedural documents (SOPs, work instructions, templates) as needed.
Assist with PV audit and inspection preparation; respond to agency queries and manage post-inspection CAPAs.
Manage PV agreements (PVAs) with CRO and licensing partners; ensure compliance with contractual safety exchange timelines.
Represent PV on cross-functional teams (Clinical, Regulatory, Medical Affairs); provide safety input into protocol amendments and IBs.

System Ownership & Team Development:

Serve as functional administrator for Veeva Vault Safety: configure workflows, manage user access, and coordinate validation with IT.
Oversee Safety-EDC reconciliation between Vault Safety and Veeva EDC for ongoing trials.
Mentor and train the junior Drug Safety Associate; conduct case-level QC and provide structured development feedback.

Requirements:

QUALIFICATIONS

Required:

Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related discipline; Master's, PharmD, or RN strongly preferred.
5+ years of progressive pharmacovigilance experience in the pharmaceutical, biotech, or CRO industry.
Demonstrated proficiency in Veeva Vault Safety or Oracle Argus for end-to-end case processing and reporting.
Hands-on experience authoring DSURs and/or PBRERs; strong technical writing skills.
Deep knowledge of ICH E2A, E2B(R3), E2C, E2D, E2E, FDA 21 CFR Part 312, and EMA GVP Modules I–IX.
Expert-level MedDRA coding; experience with signal detection methodologies.
Track record of direct regulatory interactions and safety committee participation.

Preferred:

Experience in Oncology therapeutic area.
Prior sponsor-side experience at a small or mid-size biotech.
PSMF authoring and GVP Module VII experience.
E2B electronic gateway submissions (FDA ESG, ASK-EudraCT, VigiBase).
Veeva Vault Safety administrator or system validation experience.

TECHNICAL SKILLS:

Veeva Vault Safety — case processing, workflow configuration, analytics, and E2B gateway management.
MedDRA (expert-level) and WHODrug Global coding.
Microsoft Office — advanced Excel for data analysis; Word/PowerPoint for regulatory documents.
Document management systems (Vault QMS or equivalent) for SOP and PSMF maintenance.

Corbus Culture:

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in oncology and obesity. Our mission is to help people defeat serious illness by advancing differentiated scientific approaches targeting well-understood biological pathways with significant unmet medical need. Corbus’ lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications. Our obesity program, CRB-913, is a highly peripherally restricted CB1 receptor inverse agonist designed to support meaningful weight loss while minimizing central nervous system side effects. Together, these programs reflect our commitment to advancing transformative therapies through rigorous science and clinical innovation.

Headquartered in Norwood, Massachusetts, Corbus fosters a collaborative, entrepreneurial environment where employees are empowered to make meaningful contributions and help shape the future of the company. For more information, visit corbuspharma.com and connect with us on LinkedIn. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.

Quick apply

Refine Your Search

drug safety jobs in england

Drug Safety Associate II

Laboratory Operations Assistant

Trainee Train Driver - Blackpool

(Fixed Term) Laboratory Technician, Clinical Biomarker Laboratory, Immunoassay

Sr. Drug Safety Specialist

BAS: Intelligence Analyst

Clinical Research Coordinator -Wolverhampton, UK

Aircraft Refueller

Laboratory Scientist – Genetics

Technician [Off Track]

Junior Metallurgist

Sexual Health Adviser

Research Assistant/ Associate in Translational Cancer Research

Laboratory Assistant

Medicines Management Technician

Medical Information Specialist - US Hours

Detention Custody Officer - Heathrow AP

Study Physician - Bank, Full-Time

Enterprise Account Executive - Life Sciences

Gambling Wellbeing Practitioner

I want to receive the latest job alerts for drug safety in england

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