Associate Director, Senior Patient Safety Scientist

Requirements – Education and Experience

• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Advanced knowledge of PV regulations
• Substantial pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug 
  development, with experience independently delivering safety-science activities.
• Experience in at least 2 (two)of the following: clinical development safety; signal management; periodic safety reports; safety sections of protocols/IBs/ICFs/CSRs; regulatory responses.

• Good knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines.
• MD/MSc/PhD in scientific discipline, preferred
• Intermediate understanding of epidemiology, preferred

• Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. 
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.