Associate Director, Patient Safety Scientist

• Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.   

• Represents PS on cross-functional project teams for developmental compounds and/or marketed products.  

• Has the ability to present safety information at external meetings.  

• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects. 

• Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.  

• Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.  

• Collaborates with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion.   

• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients. 

• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. 

• Authors/provides strategic  input to  regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. 

• Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement.  

• Trains junior members of the team in PS tools and systems.  
   

Requirements – Education and Experience 

• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience. 

• Intermediate knowledge of PV regulations  

• Fluent in written and verbal English 

• MD, MSc/PhD in scientific discipline, preferred 

• Basic understanding of epidemiology data, preferred