Senior Pharmacovigilance Lead: Global Safety & Signals

Biogen; Maidenhead; Vor Ort; GBP 110.000 - 140.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior Pharmacovigilance leader in the United Kingdom to guide PV activities for multiple products. You will drive safety signal management, oversee PSUR/DSUR/RMP preparation, and respond to regulatory inquiries while mentoring PV staff.

The role requires an advanced degree and extensive PV experience, with strong data interpretation and regulatory knowledge. Collaboration with Global Safety Officers and Safety MDs is essential.

Qualifikationen

• Advanced degree required (PhD, MPH, NP, PharmD, etc.).
• Significant pharmacovigilance experience including aggregate safety reports and safety signal management.
• Proficiency in interpreting, analyzing, and presenting scientific and medical data.
• Strong foundation in pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
• Basic knowledge of Excel, PowerPoint, Word, Business Objects, and safety database systems.
• Demonstrated leadership and collaborative skills within teams.
• Expertise in global safety regulations preferred.
• Experience mentoring and managing staff in pharmacovigilance.
• Ability to apply clinical judgment in safety data interpretation.

Aufgaben

• Serve as a product lead for Pharmacovigilance activities.
• Oversee and lead safety signal management processes and aggregate reports.
• Respond to safety inquiries from internal and external stakeholders.
• Review medical and scientific literature for safety information.
• Support Clinical Trial PV medical activities.
• Collaborate with leadership to hire, train, mentor, and manage staff.
• Guide Safety and cross-functional teams on global safety regulations, data analyses, and product-specific information.
• Conduct ongoing safety data reviews and signal detection activities.
• Lead signal management activities, including detection, tracking, documentation, evaluation, and reporting.
• Manage literature review activities.
• Oversee strategy, review, and finalization of PSURs, DSURs, RMPs, and related safety documents.
• Prepare scientifically robust responses to regulatory authorities.
• Collaborate on investigational programmes, clinical trial activities, and safety committee management.
• Manage ad hoc safety data analyses and information requests.

Kenntnisse

Data Analysis

Signal Detection

Literature Review

Safety Data Interpretation

Clinical Trial Regulations

Ausbildung

PhD

MPH

NP

PharmD

Tools

Excel

PowerPoint

Microsoft Word

Business Objects

Safety Database Systems

Jobbeschreibung

Jobtailor is seeking a senior Pharmacovigilance leader in the United Kingdom to guide PV activities for multiple products. You will drive safety signal management, oversee PSUR/DSUR/RMP preparation, and respond to regulatory inquiries while mentoring PV staff.

The role requires an advanced degree and extensive PV experience, with strong data interpretation and regulatory knowledge. Collaboration with Global Safety Officers and Safety MDs is essential.