Job Description

About KalVista Pharmaceuticals, Inc.

KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®-the first and only oral on-demand treatment for hereditary angioedema (HAE)-and continues to work closely with the global HAE community to improve treatment and care for this disease around the world.

For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram.

About EKTERLY® (sebetralstat)

EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide.

For more information visit EKTERLY.com.

About the role:

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 Support GPV audit/inspections including implementation of relevant CAPAs and its effectiveness

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation.

Job Tags

Full time, Contract work, Worldwide,

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