Jobs in Bloemfontein, South Africa

Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects. Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• May provide therapeutic area/indication training for the project clinical team.
• Attends and may present at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24/7 to respond urgent protocol-related questions from investigative sites, in accordance with local labor laws.

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• Board Certified.
• Typically requires 3 - 5 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
• Current knowledge of medical, scientific, and clinical landscape in applicable therapeutic area.
• Good communication, presentation, and interpersonal skills, including good command of English language (both written and spoken).
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Attention to details, flexibility, and ability to provide advice on multiple assignments.
• Current or prior license to practice medicine.
• Clinical experience in the requested medical specialty.