Responsible Pharmacist: Quality Assurance, Regulatory and QPPV - South Africa

Benefits

Additional Information

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. This pivotal role focuses on strategically shaping BeOne's presence in haematology and oncology disease areas, driving competitive success in the South African market while delivering value to patients, healthcare providers, Payors and the organisation. The position is for a Responsible Pharmacist role encompassing quality assurance, regulatory affairs, and pharmacovigilance duties, in compliance with relevant South African legislation The incumbent will be responsible for Regulatory affairs: Tasks include developing regulatory filing strategies, managing submissions and approvals, maintaining licenses, reviewing promotional materials, and coordinating responses to health authorities. Pharmacovigilance : Acting as the Local Qualified Person for Pharmacovigilance (QPPV), the incumbent ensures patient safety, case reporting, literature surveillance, and establishment of local PV systems aligned with global strategies. Quality assurance : The pharmacist oversees GMP/GDP compliance, manages the local quality management system, supports product launches and post-marketing quality activities, and handles deviations and recalls. Qualifications required: A Bachelor of Pharmacy degree, registration with the South African Pharmacy Council, at least eight years' experience in regulatory affairs and quality assurance, and proficiency in electronic quality systems and regulatory dossier requirements. Regulatory dossier management: Responsibilities include preparing and submitting product registration dossiers, managing lifecycle post-registration activities, reviewing packaging and labeling, and staying informed on regulatory intelligence. Pharmacovigilance detailed tasks: The role requires 24-hour availability for SAHPRA, monitoring legislation, ensuring submission of safety reports, managing safety communications, training staff, supporting audits/inspections, and maintaining SOPs and agreements. Quality assurance: Includes managing quality activities, batch release, documentation approval, transport validation, product traceability, audits, complaint handling, recalls, and maintaining quality agreements and documentation. Compliance and communication: To discharge all duties as required of a Responsible Pharmacist as per the Medicines & Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974, and the relevant Regulations, guidelines end ethical rules. To ensure regular management review and management meetings. The main point of contact with health authorities in collaboration with internal/global teams (QA, Medical, PV, Marketing, Supply Chain). Ensure products meet local (e.g. SAHPRA and selected African countries) and international regulatory standards; monitor legislative changes and provide strategic advice. To ensure that the Company meets its statutory requirements in terms of the Medicines & Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974, and the relevant Regulations and guidelines. To establish and ensure that Regulatory Affairs processes and Quality Systems are in place to ensure compliance in the event of Regulatory inspections Ensure responses to all inspection reports received from Regulatory Authorities are compiled and submitted within timelines. To keep company legal documents updated with Regulatory Authorities. Ensure compliance of all marketing & promotional materials in line with legal requirements. Key Working Relationships: Global: Quality Assurance. Regulatory and eCTD publishing Pharmacovigilance Supply chain. South Africa/Africa: General Manager and respective management team. Local Marketing, Medical, Pharmacovigilance and 3rd party contractors. External: Regulatory authorities, SA Pharmacy Council and trade associations. Other Qualifications/Requirements: Strong identification with BeiGene´s values and loyalty to the company Demonstrated success in a small but fast growing, entrepreneurial environment is desirable Innovative, creative, out of the box thinking Patient centricity mindset Strong digital interest Willingness to learning and continuously developing (training and coaching) Making things happen, has the right level of implementation skills High social competence and capacity for teamwork Highly motivated, solution oriented and a positive attitude Success, service, and commercial oriented thinking and working Valid driver's license Fluency in both verbal and written English Computer Skills: Standard Computer Skills required (MS Office) Location: Johannesburg NA Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies