Qualified Person for Pharmacovigilance (QPPV)

Role Overview

You will act as the company’s designated Qualified Person for Pharmacovigilance, taking ownership of the entire safety-monitoring framework for marketed pharmaceutical products. On a day-to-day basis, this means making sure every adverse event is captured, investigated, and reported to the relevant authorities within strict legal deadlines, while also keeping the pharmacovigilance system audit-ready and continuously improving it through training and corrective actions. Your work directly protects patients and preserves the company’s regulatory standing, making you a critical bridge between internal teams and health authorities.

Key Responsibilities

• Build and maintain the pharmacovigilance system, including writing and updating SOPs, overseeing staff training, managing CAPA processes, and keeping all PV documentation current and inspection-ready.
• Track and process adverse drug reactions and product quality complaints from initial receipt through assessment, follow-up, and final regulatory submission, ensuring no case is missed or delayed.
• Detect and evaluate safety signals using available data, then contribute to risk management strategies and the ongoing safety profile of each product.
• Prepare and submit Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs), and other post-marketing safety documents in line with Kenyan and applicable international requirements.
• Coordinate and lead pharmacovigilance inspections and internal or external audits, acting as the main point of contact for regulators and auditors and ensuring findings are resolved promptly.
• Deliver pharmacovigilance training to internal employees, field staff, and other stakeholders so that everyone understands their role in reporting adverse events and maintaining compliance.
• Serve as the designated contact for product safety questions from regulators, healthcare professionals, and partners, providing accurate and timely responses.

Requirements & Qualifications

• Bachelor’s Degree in Pharmacy from a recognised institution.
• A formal certificate or specialised training in Pharmacovigilance (e.g., a postgraduate certificate, diploma, or accredited short course in drug safety).
• Current registration as a pharmacist with the Pharmacy and Poisons Board (PPB) Kenya, with a valid practising licence.
• At least 2 years of hands-on experience in pharmacovigilance, regulatory affairs, quality assurance, or a related pharmaceutical function; direct industry experience is a clear advantage.
• Strong working knowledge of pharmacovigilance regulations, ADR reporting systems, ICSR processing, and safety data management principles.
• Excellent attention to detail, organisational skills, and the ability to meet strict regulatory deadlines while managing multiple priorities.
• Good written and verbal communication skills, with the confidence to interact with regulators, auditors, and internal teams.