Senior Pharmacovigilance Manager

Quanta part of QCS Staffing; England; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading global biopharmaceutical company is seeking a Senior Pharmacovigilance Manager in Hertfordshire. The role involves managing safety data for medicinal products and ensuring compliance with regulatory standards. Ideal candidates will have a Master’s degree and extensive experience in drug safety and pharmacovigilance.

Qualifications

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

Responsibilities

• Manage case-processing activities for medicinal products.
• Conduct worldwide literature research for safety data.
• Manage Aggregate Reports related to pharmacovigilance.

Skills

Drug safety

Pharmacovigilance

Data analysis

Regulatory 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

Client: Quanta, part of QCS Staffing

Location: Hertfordshire, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: d8f361d5ee4d

Job Views: 20

Posted: 22.06.2025

Expiry Date: 06.08.2025

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:

• Manage case-processing activities through all phases of development for medicinal products licensed/distributed by our client and subsidiaries.
• Conduct worldwide/national literature research to detect meaningful safety data.
• Handle data reconciliation activities with internal functions as 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 (SSP), managing ADRs/ICSRs from clinical trials, drafting Investigator's Brochure (IB), and Development Safety Update Reports (DSUR).
• Manage Reference Safety Information over time.
• Support EU QPPV and PV Medical Unit in signal management from detection to communication, including actions.
• Collaborate on Post Authorization Safety Studies and Patient Support Programs, reviewing protocols/reports, training personnel, and analyzing data.
• Adhere to local and global processes and regulations related to pharmacovigilance activities.

Desirable Experience:

• Master’s degree in life sciences.
• 8+ years of drug safety and pharmacovigilance experience in the pharmaceutical industry.
• 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).
• Proven ability to analyze and report safety information in compliance with regulations.
• Experience preparing regulatory reports for investigational drugs.
• Proficiency in Word, Excel, PowerPoint, Outlook.

If interested, please apply now.