Global Safety Officer (Pharmacovigilance)

Role Summary

The Global Safety Officer (Director/Senior Director) serves as the safety expert for all clinical stage assets and marketed products at KalVista and is accountable for the safety strategy and major safety deliverables for each compound, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, and management of benefit-risk profile for assigned compounds and products. Responsible for keeping senior management informed of safety issues and will work closely with Clinical Development and Operations as medical advisor.

Responsibilities

• Monitor the benefit-risk profile of assigned compounds in an ongoing fashion and in accordance with Company and Pharmacovigilance (PV) processes
• Support and lead PV risk management processes including Product Safety PV Operations Review Team meetings
• Identify, prioritize and analyze safety signals and participate in discussions in relevant safety teams/committees
• Perform ongoing review of emerging safety data from various sources including published literature
• Ensure appropriate clinical safety risk communication and escalation to senior management
• Support PV vendor oversight and continuously maintain and improve effective systems to fulfil the requirements for signal detection and aggregate report compilation and reporting
• Produce high quality aggregate reports and responses to regulatory queries
• Provide strategic and proactive safety input into clinical development plans and update safety related sections of study documents including protocols, IB, and Inform Consent
• Ensure adequate labelling of safety related information
• Represent safety/PV in cross-functional submission teams
• Ensure generation, consistency, and quality of safety sections in submission documents
• Participate in the development and review of safety agreements with third parties
• Ensure effective and timely delivery of: aggregate reports including Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Report (PSUR/PBRERs), Development Safety Update Reports (DSURs), Development Risk Management Plans (DRMPs) and Risk Management Plans (RMPs) (core and European Union (EU), Benefit Risk Statements, Safety section of Core Datasheets, answers to assigned safety relevant Health Authority (HA) requests and complex Answer to Query (A2Q), Safety relevant communications such as Dear Health Care Provider (DHCP) letters;
• Work closely with Global Head of PV, QPPV and other PV leaders in developing and maintaining a compliant PV system to support clinical development and commercialization of KalVista products

Qualifications

• M.D. degree or equivalent (e.g., D.O. or M.B.) or advanced graduate degree in a field related to pharmaceutical sciences (e.g., Advanced Pharmacist degree)
• MPH or other epidemiology degree preferred
• 5+ years of PV experience, with at least 2 years within a biopharmaceutical company
• Appropriate experience with Regulatory Agency interactions including marketing authorization applications
• Strong understanding of global regulatory requirements (FDA, EMA, ICH guidelines)
• Proven evidence of effective delivery of high-quality safety relevant documents
• Experience with PV vendor assessment and oversight
• Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics
• Effectively communicates in written and spoken English
• Communicates complex issues in an understandable, effective and relevant manner
• Strong influencing skills with the ability to explain and defend a position in the face of opposition
• Strategic focus to activities and planning, with proactive planning and prioritization skills
• Takes ownership of appropriate issues and appropriately delegates
• Technical expertise in pharmacovigilance and clinical safety