Director, Global Safety – Global Periodic Aggregate Safety Reports

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🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

👔 Director

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Develop Pharmacovigilance Operations strategy for production and submission of periodic aggregate safety reports (PASRs) • Lead all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product life cycle • Lead a global team with members in the US, EU, and Amgen India • Participate in cross-functional activities to ensure compliance and consistency with PASR preparation • Provide global leadership for the PASR team and ensure regulatory requirements are met • Develop and maintain the Global Periodic Reports Schedule, Standards, and Procedures • Liaise with external vendors, Global Patient Safety, and cross-functional teams in creating PASRs • Undertake activities delegated by the QPPV and maintain inspection readiness • Serve as point of contact for Health Authority Inspections and Internal Process Audits • Manage global staff in the functional area

🎯 Requirements

• Degree educated: BS, RPH, RN HCP • Extensive experience in Drug Safety with demonstrated knowledge of global aspects of pharmacovigilance • Strong knowledge of processes and global regulations for pharmacovigilance and periodic aggregate safety reporting • Understanding of emerging regulatory requirements and their implications • Subject matter expertise and technical excellence • Experience working on cross-functional teams • Strong leadership, independence, networking, influencing, and managerial skills • Proven leadership skills in execution of goals and processes across a global team • Ability to organize, plan, and prioritize workload • Ability to effectively manage competing priorities and timelines • Excellence in oral and written English

🏖️ Benefits

• Vast opportunities to learn and move up and across the global organization • Diverse and inclusive community of belonging • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits • Fully remote work option, or flexible home working with occasional office presence near Cambridge or Uxbridge