CL
Cosmos Limited
Qualified Person for Pharmacovigilance (QPPV) at Cosmos Limited
KenyaFull TimeMid-Senior Level
Stand out to recruiters
Get an ATS-compliant resume tailored to roles like this one.
Cosmos Limited
Get an ATS-compliant resume tailored to roles like this one.
Job Purpose
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.