ARTO Recruitment are looking for expert Drug Safety Physicians to join a global pharmaceutical company focused on changing the lives of patients living with severe diseases.
This is a permanent position located in Berkshire.
· Being one of the safety experts for their assigned products.
· Providing occasional training to project teams or at project related external meetings on medical issues or pharmacovigilance.
· Contributing to the scientific analysis and review of various sources of safety data using their knowledge of the regulations.
· Managing and overseeing the identification of risks and prioritizes the risks and mitigation actions that provide value for patients.
· Reviewing of appropriate data from product complaints database for patient safety implications.
· Reviewing and providing safety input for relevant clinical or regulatory documents for assigned products (IB, protocols, RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts, and OSS/Recall Medical Assessments, etc).
· Providing support to SL, Benefit Risk Team (BRT) for Global Labelling Committee (GLC), Benefit Risk Board (BRB), and PVU activities.
· Producing accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
· Managing the synthesis and interpretation of safety and epidemiological data, identifying insights that can be used to differentiate products and support decision making.
· Robust and comprehensive safety analyses experience of individual and aggregate data to support safety signal detection, evaluation, and management in the context of overall benefit risk balance.
· Valued expertise and input to life-cycle product teams.
· Decisive, appropriate input and responses to ad hoc safety issues.
· Viewed as a recognized expert on responsible product areas within the organization.
· Previous experience in Drug Safety coupled with the ability to work in matrix environment.
· Formal training in analytic skills such as biostatistics or epidemiology, ideally.
· Project management experience and pre-clinical experience/knowledge.
· Clinical trial experience with prior experience in a relevant scientific field.
Please get in touch if you would like to discuss this role in more detail. You can click the link via the website, or reach out directly (firstname.lastname@example.org / +44 203 393 5906 / +44 7817280476)