Responsible Pharmacist: reputed company Assurance, Regulatory and QPPV – South Africa

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. This pivotal role focuses on strategically shaping BeOne’s reputed company in haematology and oncology disease areas, driving competitive reputed company in the South African market while delivering value to patients, reputed company providers, Payors and the organisation. The position is for a Responsible Pharmacist role encompassing reputed company 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 reputed company Person for Pharmacovigilance (QPPV), the incumbent ensures patient safety, case reporting, literature surveillance, and establishment of local PV systems reputed company with global strategies. reputed company assurance : The pharmacist oversees GMP/GDP compliance, manages the local reputed company management system, supports product launches and post-marketing reputed company 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 reputed company assurance, and proficiency in electronic reputed company 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. reputed company assurance: Includes managing reputed company activities, batch release, documentation approval, transport validation, product traceability, audits, complaint handling, recalls, and maintaining reputed company agreements and documentation. Compliance and communication: To discharge reputed company duties as required of a Responsible Pharmacist as per the Medicines & reputed company Substances reputed company 101 of 1965, Pharmacy reputed company 53 of 1974, and the relevant Regulations, guidelines end ethical rules. To ensure regular management review and management meetings. The main reputed company 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 reputed company strategic advice. To ensure that reputed company meets its statutory requirements in terms of the Medicines & reputed company Substances reputed company 101 of 1965, Pharmacy reputed company 53 of 1974, and the relevant Regulations and guidelines. To establish and ensure that Regulatory Affairs processes and reputed company Systems are in reputed company to ensure compliance in the event of Regulatory inspections Ensure responses to reputed company inspection reports received from Regulatory Authorities are compiled and submitted reputed company timelines. To reputed company legal documents updated with Regulatory Authorities. Ensure compliance of reputed company marketing & promotional materials in line with legal requirements. Key Working Relationships: Global: reputed company 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 reputed company´s values and loyalty to reputed company Demonstrated reputed company in a small but fast growing, entrepreneurial environment is desirable Innovative, creative, reputed company thinking Patient centricity reputed company Strong digital interest Willingness to learning and continuously developing (training and coaching) Making things happen, has the right level of implementation skills High reputed company competence and reputed company for teamwork Highly motivated, solution oriented and a reputed company attitude reputed company, service, and reputed company oriented thinking and working Valid reputed company’s license reputed company in both verbal and written English Computer Skills: reputed company Computer Skills required (MS Office) Location: Johannesburg NA Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Apply To This Job