Pharmacovigilance Scientist

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.

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 and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.

For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.

About the role:

The PV Scientist act as the responsible person for the UK MHRA, working closely with the EU/UK QPPV to ensure regulatory compliance in the UK, the EU and other regions. In addition, the PV scientist will work closely with the Global Safety Officer in the collection, analysis, and reporting of safety data and would also provide operational support and oversight of third- party vendors. Position will work closely Work closely with Medical Affairs, Regulatory Affairs, Clinical Development, and Quality teams.

Responsibilities:

• Work closely with the Global Safety Officer, QPPV and other PV team members to develop solutions and implement action plans for identified safety and operational issues to mitigate risks, promote compliance and efficiencies
• Act as the Responsible Person for PV in the UK and to work closely with the EU/UK QPPV and Regional PV Heads in supporting local Pharmacovigilance activities
• Assess and analyse adverse event (AE) data from clinical trials, post-marketing surveillance, and literature reports
• Contribute to signal detection, risk management, and safety assessments
• Assist in the preparation of aggregate safety reports (e.g., PSURs, DSURs, PADERs)
• Ensure compliance with global regulatory requirements, including FDA, EMA, MHRA, and ICH guidelines
• Assist in the development and implementation of risk management plans (RMPs)
• Support responses to health authority queries related to drug safety
• Contribute to the preparation of safety-related documents, including investigator brochures (IBs) and labelling updates
• Where third parties are involved in PV activities or commercialisation/distribution of KalVista products, ensure relevant contract/safety data exchange agreements are in place and roles and responsibilities of the parties are well described
• Supports 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
• 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 years pharmacovigilance experienced gained in a pharmaceutical/Biotechnology
• Expert knowledge in managing pharmacovigilance of products in development or marketed
• Knowledge of global pharmacovigilance regulatory requirements (FDA, EMA, MHRA, and ICH guidelines.)
• Experience participating in inspection/audits including CAPA management
• Technical expertise in pharmacovigilance and clinical safety
• Effectively communicates in written and spoken English
• Ability to work autonomously, as well as act as 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

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.