12 Month initial Contract
Remote working, UK
Pay rate up to £140 per hour via Umbrella inside IR35
Provides high level medical expertise in the day-to-day safety evaluation and risk management of key HIV assets in the post-marketing setting. As part of a skilled team of physicians and scientists:
• Conducts routine pharmacovigilance activities including signal detection activities and signal validation and assessment
• Authors and reviews key regulatory documents (e.g. DSURs, EU RMPs and PBRERs) as well as responses to regulatory questions
• Helps to identify the need for product labelling updates, and drives proactive implementation of risk management initiatives
• Ensures that adverse event and other safety information is efficiently evaluated and accurate in order to meet global compliance and regulatory requirements
• Leads presentation of safety-related findings and data to senior stakeholders and governance boards
• Shows confidence, credibility and influence at all levels of the complex organisational matrix
You will have safety Evaluation and Risk Management experience in post-marketing setting, including detection activities, authoring of periodic reports, performing safety evaluations and responses to regulatory authority questions.
Collaborative working within a team environment. Importantly, we would like a candidate who can proactively contribute to the team deliverables and is not solely a medical reviewer.