About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.
For more information about KalVista, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.
About Sebetralstat
Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.
About the Role:
Reporting into the Global Head of Medical Safety, the Manager/Senior Manager Pharmacovigilance Operations serves as the safety operational expert for all intake and management of safety data from KalVista clinical trials and marketed products. Contributes to the development, implementation, and successful oversight of PV service providers and commercial partners to ensure fulfillment of internal standards and global regulatory requirements. Manages wider departmental operational activities including ownership and development of specific operational procedures.
The Safety Operations Manager will provide safety operational input into study-related documents, implement safety management plans, ensure compliance with SOPs relevant to patient safety, and keep senior management informed of operational issues/risks impacting patient safety and compliance. Act as the PV responsible person for the UK Commercial business. The position will work closely with Clinical Development, Clinical Operations, Commercial, and Regulatory Affairs and will support inspections and audits including CAPA Management.
Responsibilities:
* Work closely with the Head of Global PV, QPPV, and other PV leadership to develop solutions and implement action plans for identified safety issues to mitigate risks, promote compliance, and efficiencies.
* Act as the responsible person for the UK commercial business and work closely with the EU/UK QPPV to ensure successful business support and regulatory compliance.
* Provide operational management and oversight into intake, management, and timely reporting of ICSR from clinical trials and post-marketing sources.
* Establish and maintain Global PV mailbox and ensure up-to-date reconciliation of safety data received from various sources.
* Maintain oversight of screening of global scientific and medical literature for relevant efficacy and safety information on company products during development and commercialization.
* Review and provide operational input into study-related documents (e.g., trial protocols) and safety aspects of other trial documents as required.
* Ensure safety management plans are developed for each study where KalVista is collaborating with selected vendors to conduct its clinical trials.
* Maintain oversight of Safety Database and ensure relevant dictionaries are in place for case processing.
* Where third parties are involved in PV activities or commercialization/distribution of KalVista products, ensure relevant contract/safety data exchange agreements are in place and roles and responsibilities of the parties are well described.
* Direct the planning, coordination of data requests, and contribute to preparation, review, and quality checks of aggregate reports (DSUR, PSURs PADER, PBRERs).
* Develop and implement with Head of PV, key performance indicators for core PV tasks including vendor activities and escalate operational risks/issues impacting patient safety and compliance to Head of PV.
* Support various PVG meetings in terms of slide deck development, collation of meeting materials, and meeting minutes.
* Maintain tracking system for various safety-related activities including KPIs for internally and externally managed processes, aggregate report schedules, and aspects of PV regulatory intelligence.
* Ensure appropriate systems are in place to monitor company-sponsored Website/social media sites.
* Contribute to the development and maintenance of the PSMF.
* Participate in regulatory inspections and audits including CAPA implementation and evaluation of its effectiveness.
* Assist in developing SOPs, work instructions, forms, and templates, and provide PV training as needed.
* Take on additional tasks/responsibilities as deemed necessary by Head of department.
Qualifications:
* Minimum bachelor’s degree in a life science discipline.
* Minimum of 5-7 years pharmacovigilance experience gained in a pharmaceutical/Biotechnology.
* Expert knowledge in managing pharmacovigilance of products in development or marketed.
* Detailed comprehension of global pharmacovigilance regulatory requirements.
* Experience of working with and managing vendors, partners, and CROs.
* Experience participating in inspections/audits including CAPA management.
* Technical expertise in pharmacovigilance and clinical safety.
* Effectively communicates in written and spoken English.
* Strong influencing skills with the ability to explain and defend a position in the face of opposition.
* Ability to work autonomously, as well as act as a strong team player.
* Strategic focus to activities and planning, with proactive planning and prioritization skills.
* Takes ownership of appropriate issues and appropriately delegates.
* Strong documentation and archiving skills.
KalVista is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
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