Senior Patient Safety /Pharmacovigilance Specialist

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re a part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We have reimagined the most important aspects of our work lives, creating more flexibility than ever before by applying a whole company mindset to plan around our personal needs and work preferences and in turn we are flexible to meet the needs of the business and honor our role in driving a thriving company-wide culture.

LIVE - WHAT YOU WILL DO

Let’s do this. Let’s change the world. Join Amgen’s Patient Safety team for a rewarding opportunity to impact patient safety. This role is integral to delivering pharmacovigilance requirements, ensuring compliant and efficient performance of local safety activities. It requires a deep understanding of local legislative requirements and practices for all Amgen and in-licensed products in Australia and New Zealand. Key responsibilities include maintaining compliance with safety regulations, contributing to the Global Safety network, and coordinating local drug safety activities. This is a temporary, 12-month contract position reporting to the APAC Director of Global Patient Safety.

KEY RESPONSIBILITIES:

• Provide specialist technical expertise and act as safety subject matter expert for defined subject areas
• Perform core safety activities including timely & accurate capture, routing, follow-up and submission of adverse events reported for ANZ, local medical literature screening, timely preparation and submission of periodic safety reports, urgent safety communications, DHCPs and DILs as required, tailoring of core risk management plans to local regulatory requirements and assist with local implementation of additional risk minimization activities
• Assist in local safety review of local study protocols, plans/vendor contracts of local market research studies, patient support programmes and Amgen sponsored websites/social media projects, to ensure safety contract language, training, monitoring and data collection are appropriately addressed
• Assist Safety Country Lead in escalation of product safety issues from local Regulator or HCP bodies to Therapeutic Safety Teams and /or regional Safety Management and QPPV, and uses expertise to contribute to responses for internal and externally sourced safety questions, collaborating with Regulatory or Medical Information for delegated products or issues
• Assist in training on adverse event reporting obligations for local staff and stakeholders