Qualified Person for Pharmacovigilance (QPPV) at Cosmos Limited

Job Purpose

• We are seeking a highly motivated and experienced Qualified Person for Pharmacovigilance (QPPV) to oversee and maintain the company's Pharmacovigilance system, ensuring compliance with applicable regulatory requirements and industry standards. The successful candidate will act as the primary contact for product safety matters, manage adverse event reporting, support regulatory inspections and audits, and ensure the continued safety and quality of marketed pharmaceutical products.

Key Responsibilities

• Establish, maintain, and oversee the Pharmacovigilance System, including SOPs, training, CAPAS, audits, inspections, and Pharmacovigilance documentation.

• Ensure timely collection, assessment, reporting, and maintenance of adverse drug reactions (ADRs) and product quality complaints.

• Lead signal detection, evaluation, and risk management activities.

• Prepare, review, and submit regulatory safety reports, including Individual Case Safety Reports (ICSRS), Periodic Safety Update

• Reports (PSURS/PBRERS), Risk Management Plans (RMPs), and post-marketing safety evaluations, ensuring compliance with regulatory requirements and reporting timelines.

• Lead and coordinate Pharmacovigilance inspections and regulatory audits.

• Conduct Pharmacovigilance training for employees and other relevant stakeholders.

Qualifications and Experience

• Bachelor's Degree in Pharmacy.

• Certificate in Pharmacovigilance.

• Registered Pharmacist with the Pharmacy and Poisons Board (Kenya).

• Minimum of 2 years' experience in Pharmacovigilance, Regulatory Affairs, Quality Assurance, or a related pharmaceutical field. Experience within the pharmaceutical industry will be an added advantage.