Senior Pharmacovigilance Manager

Quanta part of QCS Staffing; England; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A global biopharmaceutical company in Hertfordshire seeks a Senior Pharmacovigilance Manager to oversee safety data management and compliance with regulations. The ideal candidate will have over 8 years of experience in drug safety, a Master’s degree in life sciences, and knowledge of adverse event reporting regulations. This role offers an opportunity to contribute to high-quality medicines for rare diseases.

Qualifications

• 8+ years of drug safety and pharmacovigilance experience.
• Experience in audits and inspections.
• Knowledge of UK, FDA, EU, and international adverse event reporting regulations.

Responsibilities

• Manage case-processing activities through all development phases.
• Handle data reconciliation activities with internal support functions.
• Compile, update, and review Dossier and Printouts related to Pharmacovigilance.

Skills

Drug safety and pharmacovigilance

Data analysis

Regulatory compliance

Safety information reporting

Education

Master’s degree in life sciences

Tools

Veeva Vault

Word

Excel

PowerPoint

Outlook

Job description

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Senior Pharmacovigilance Manager, Hertfordshire

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Client:

Quanta part of QCS Staffing

Location:

Hertfordshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

d8f361d5ee4d

Job Views:

44

Posted:

12.08.2025

Expiry Date:

26.09.2025

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Job Description:

Senior Pharmacovigilance Manager – Biopharmaceuticals - Hertfordshire / Remote

Our client, a global biopharmaceutical company with plants across Europe and North America, is looking for a Senior Pharmacovigilance Manager to join their team in the UK.

This is your chance to be part of one of the top players in the field of plasma-derived products, supplying high-quality medicines treating rare diseases worldwide.

Essential Duties and Responsibilities include:

• Manage case-processing activities through all development phases, addressing ADRs/Special Situations related to medicinal products licensed/distributed by our client and subsidiaries.
• Manage worldwide/national literature research to detect meaningful safety data.
• Handle data reconciliation activities with internal support functions per company procedures.
• Manage Aggregate Reports (PSURs, PAERs, RMPs, AdCOs) for licensed/distributed medicinal products.
• Compile, update, and review Dossier and Printouts (SPC/PI) related to Pharmacovigilance in collaboration with Global Regulatory Affairs.
• Support Clinical Research in drafting Safety Study Plans, managing ADRs/ICSRs from clinical trials, and preparing Investigator's Brochures and DSURs.
• Manage Reference Safety Information over time.
• Assist EU QPPV and PV Medical Unit in signal management from detection to communication and action management.
• Collaborate on Post Authorization Safety Studies and Patient Support Programs, including protocol/reports review, personnel training, and data analysis.
• Ensure adherence to local and global processes, regulations, and guidelines.

Desirable Experience:

• Master’s degree in life sciences.
• 8+ years of drug safety and pharmacovigilance experience.
• Experience in audits and inspections.
• Experience with safety databases, preferably Veeva Vault.
• Knowledge of UK, FDA, EU, and international adverse event reporting regulations per ICH guidelines.
• Experience managing Aggregate Reports (PSUR/PAER/RMP).
• Competence in safety information analysis and reporting per global regulations.
• Experience preparing investigational regulatory reports.
• Proficiency in Word, Excel, PowerPoint, Outlook.

If interested, please apply now.

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