Medical Advisor- Infectious Diseases and Vaccines, Home-Based
- Madrid
- Permanente
- Tiempo completo
- 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.