Qualified Person Responsible For Pharmacovigilance
Pharmacist ~ Quality Assurance ~ Regulatory ~ Manufacturing
Pretoria – Gauteng – South Africa
Our client in the pharmaceutical industry is seeking a highly experienced, detail-oriented Qualified Person Responsible for Pharmacovigilance (QPPV) who will also serve as the Deputy Responsible Pharmacist. The successful candidate will play a critical role in establishing, maintaining, and continuously improving a comprehensive pharmacovigilance system that meets all regulatory and quality requirements. This role is essential in maintaining the safety, efficacy, and compliance of medicinal products within a dynamic and quality-driven environment.
Key Responsibilities
As QPPV:
- Establish, oversee, and maintain the company’s pharmacovigilance system, including the Pharmacovigilance System Master File (PSMF).
- Ensure appropriate SOPs and reporting systems are in place for the collection, evaluation, and submission of safety data.
- Serve as the primary contact for pharmacovigilance matters with the relevant health authorities.
- Monitor signal detection, risk assessments, and benefit-risk evaluations for all marketed products.
- Oversee safety narratives, risk management plans (RMPs), and post-marketing surveillance activities.
- Coordinate product recalls or safety-related communications and ensure audit readiness.
- Promote a culture of safety awareness and ensure all internal teams are trained in pharmacovigilance processes.
As Deputy Responsible Pharmacist:
- Ensure full compliance with legislative and regulatory requirements under applicable Acts and Good Pharmacy Practice (GPP), Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP).
- Implement, maintain, and oversee the Quality Management System (QMS) across all relevant functions.
- Act as the liaison with regulatory authorities on licensing, inspection, and product release matters.
- Review and authorise batch documentation for product release in line with registered specifications.
- Oversee the management of product quality complaints, recalls, and adverse drug reactions.
- Promote a culture of compliance, continuous improvement, and professional ethics throughout the organisation.
Minimum Requirements
- BPharm degree
- Registration with SAPC
- 2–5 years’ relevant experience in a pharmaceutical manufacturing, distribution, or regulatory environment.
- Strong understanding of GMP, GDP, SAHPRA and SAPC legislation, and pharmacovigilance frameworks.
- Solid experience working with Quality Management Systems (QMS), including deviation management, CAPA, and change control.
- Excellent communication, leadership, and analytical skills with a commitment to maintaining quality standards.
This role presents an exciting opportunity for a registered pharmacist passionate about compliance, quality, and patient safety within a progressive pharmaceutical company. If you have a meticulous approach and thrive in a regulated environment, this position will enable you to make a meaningful impact. Apply now and join a company that values professionalism, ethical practice, and career growth.