Pharmacovigilance Scientist

KalVista Pharmaceuticals, Inc.; Salisbury; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company is seeking a PV Scientist to ensure regulatory compliance in the UK and collaborate with various teams. The role involves safety data analysis, risk management, and operational support in pharmacovigilance activities.

Qualifications

• 5 years of pharmacovigilance experience in a pharmaceutical or biotechnology setting.
• Knowledge of global pharmacovigilance regulatory requirements (FDA, EMA, MHRA, ICH).

Responsibilities

• Develop solutions for safety and operational issues to mitigate risks.
• Assess and analyze adverse event data from clinical trials.
• Ensure compliance with global regulatory requirements.

Skills

Planning

Documentation

Teamwork

Independent Work

Education

Bachelor’s degree in a life science discipline

Job description

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. We have also completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and 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, seetralstat 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 acts 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. The role involves working closely with the Global Safety Officer in the collection, analysis, and reporting of safety data, as well as providing operational support and oversight of third-party vendors. The position will collaborate with Medical Affairs, Regulatory Affairs, Clinical Development, and Quality teams.

Responsibilities

1. Work closely with the Global Safety Officer, QPPV, and PV team members to develop solutions and implement action plans for safety and operational issues to mitigate risks and promote compliance and efficiencies.
2. Act as the Responsible Person for PV in the UK and support local Pharmacovigilance activities in collaboration with the EU/UK QPPV and Regional PV Heads.
3. Assess and analyze adverse event (AE) data from clinical trials, post-marketing surveillance, and literature reports.
4. Contribute to signal detection, risk management, and safety assessments.
5. Assist in the preparation of aggregate safety reports (e.g., PSURs, DSURs, PADERs).
6. Ensure compliance with global regulatory requirements, including FDA, EMA, MHRA, and ICH guidelines.
7. Assist in developing and implementing risk management plans (RMPs).
8. Support responses to health authority queries related to drug safety.
9. Contribute to the preparation of safety-related documents, including investigator brochures (IBs) and labeling updates.
10. Ensure relevant contract/safety data exchange agreements are in place when third parties are involved in PV activities or commercialization/distribution of KalVista products, clearly defining roles and responsibilities.
11. Support PVG meetings with slide deck development, meeting materials, and minutes.
12. Maintain tracking systems for safety activities, KPIs, report schedules, and PV regulatory intelligence.
13. Contribute to the development and maintenance of the PSMF.
14. Participate in regulatory inspections and audits, including CAPA management.
15. Assist in developing SOPs, work instructions, forms, templates, and provide PV training as needed.
16. Take on additional tasks as deemed necessary by the Head of Department.

Qualifications

1. Bachelor’s degree in a life science discipline (minimum).
2. At least 5 years of pharmacovigilance experience in a pharmaceutical or biotechnology setting.
3. Expertise in managing pharmacovigilance of products in development or marketed.
4. Knowledge of global pharmacovigilance regulatory requirements (FDA, EMA, MHRA, ICH).
5. Experience with inspections and audits, including CAPA management.
6. Technical expertise in pharmacovigilance and clinical safety.
7. Proficiency in written and spoken English.
8. Ability to work independently and as part of a team.
9. Strong planning, prioritization, ownership, and documentation skills.

KalVista is an equal-opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Notice to Recruiters & Staffing Agencies

Our job openings are for direct applications. Unsolicited CVs sent to KalVista employees are property of KalVista and will not incur a fee unless a formal agreement is in place. Unauthorized contact with hiring managers outside the Talent Acquisition team will disqualify agencies from consideration.