Senior Pharmacovigilance Manager

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Senior Pharmacovigilance Manager, Hertfordshire

Client: Quanta part of QCS Staffing

Location: Hertfordshire, United Kingdom

Job Category: Other

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EU work permit required: Yes

Job Reference: d8f361d5ee4d

Job Views: 7

Posted: 26.04.2025

Expiry Date: 10.06.2025

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 include:

• Manage case-processing activities through all development phases, addressing ADRs/Special Situations related to licensed/distributed medicinal products.
• Conduct 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, review Dossier and Printouts (SPC/PI) related to Pharmacovigilance, collaborating with Global Regulatory Affairs.
• Support Clinical Research in drafting Safety Study Plans (SSP), managing ADRs/ICSRs from trials, and preparing Investigator's Brochures and DSURs.
• Manage Reference Safety Information over time.
• Support EU QPPV and PV Medical Unit in signal management, from detection to communication.
• Collaborate on Post Authorization Safety Studies and Patient Support Programs, including protocol review, training, and data analysis.
• Ensure adherence to local and global regulations and guidelines related to pharmacovigilance activities.

Desirable Experience:

• Master’s degree in life sciences.
• 8+ years in drug safety and pharmacovigilance.
• Experience with 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.
• Experience preparing investigational regulatory reports.
• Proficiency in Word, Excel, PowerPoint, Outlook.

If this role interests you, please apply now.