QUALIFICATION:- Degree or Diploma in Nursing, registered with the South African Nursing Council (SANC). Basic TB
& Enrolment Oversee study-specific patient recruitment, pre-screening, screening, and enrolment of eligible and troubleshoot obstacles in the screening and pre-screening process Conduct study-specific training with study-related queries during screening and enrolment Enforce procedures, policies, practices, and standards Required minimum education and training: Professional Nurse or equivalent Degree in Health Science related field
& Enrolment Oversee study-specific patient recruitment, pre-screening, screening, and enrolment of eligible and troubleshoot obstacles in the screening and pre-screening process Conduct study-specific training with study-related queries during screening and enrolment Enforce procedures, policies, practices, and standards Required minimum education and training: Professional Nurse or equivalent Degree in Health Science related field
interpretation of safety information collected from pre-clinical through to post-marketing, including medical requests on all drug safety matters from Regulatory Authorities for product portfolio. Support the collation interpretation of safety information collected from pre-clinical through to post-marketing, including medical requests on all drug safety matters from Regulatory Authorities. Involvement in the development of Risk Management bid defence meetings. Previous experience with authoring/reviewing PV procedures is preferred. Experience
interpretation of safety information collected from pre-clinical through to post-marketing, including medical requests on all drug safety matters from Regulatory Authorities for product portfolio. Support the collation interpretation of safety information collected from pre-clinical through to post-marketing, including medical requests on all drug safety matters from Regulatory Authorities. Involvement in the development of Risk Management bid defence meetings. Previous experience with authoring/reviewing PV procedures is preferred. Experience
consent, and enrol study participants; conduct tablet-based interviews with enrolled participants, and symptoms
mitigation plans in place to engage. Regulatory authorities when earliest signs of delay emerge. Proactively standards in the following process areas: Marketing Authorization Applications License maintenance e.g., Renewals Labelling and Artwork Management Robust Health Authority interactions To track and manage all GRP activities job profile. Marketing Authorization Applications: Submit Marketing Authorization Applications to the SA SA Health Authority according to SA HA guidelines and GRP, in the shortest possible time based on business
maintenance in accordance with the latest regulatory authority requirements. Registered with the South African skills. Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including skills. Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including compliance with the relevant Health Regulatory Authorities, Medicines, and Related Substances Control Act regulatory affairs or experience at a health authority. Implement a registration plan and provide business
maintenance in accordance with the latest regulatory authority requirements. Registered with the South African skills. Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including skills. Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including compliance with the relevant Health Regulatory Authorities, Medicines, and Related Substances Control Act regulatory affairs or experience at a health authority. Implement a registration plan and provide business
curtailed. - Cultivate robust relationships with authorities, guaranteeing legal compliance and shared ecological internal compliance audits with precision and authority. - Enhance the company's environmental management