Medical Safety Manager

Pracovní nabídka

Medical Safety Manager

The incumbent is responsible for overseeing medical safety for clinical trials (Phase I-IV) globally. The role focuses on identifying, evaluating, and managing safety risks throughout the clinical development process, ensuring compliance with regulatory requirements and company safety standards. The incumbent will provide an unbiased medical, scientific and therapeutic expertise. Member of the Medical Safety team supporting clinical trials (Phase I-IV) at a global level reporting to the Head of Global Vigilance, Medical Safety & Device Complaint Management

Medical Safety Manager activities:

• Review clinical protocols and provide input on safety evaluations
• Develop and implement Safety Monitoring Plans for clinical trials (Phase I-IV)
• Review safety sections of the ICF
• Provide safety-related input to other study documents and processes, as needed
• Review and evaluate masked clinical data and adverse event reports from clinical trials, laboratory results, and other safety-related information to identify safety signals
• Identify potential safety risks in clinical trials and develop risk minimization measures to address identified safety concerns
• Identify and investigate safety signals that emerge from adverse event reports and relevant literature
• Prepare safety-related communications for investigators, ethics committees and regulatory authorities
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Participate in safety review committees, data monitoring committees, Clinical Trial Safety Data Review meetings and other meetings as directed by the charter/manager
• Provide medical expertise for safety updates and submissions
• Contribute to the preparation of blinded safety-related regulatory documents/dossiers (e.g., CTD section 2.7.4) including but not limited to Investigator's Brochures and Development Safety Update Reports (DSURs)
• Ensure compliance with global safety regulations and guidelines, including ICH, FDA and EMA requirements
• Complete other medical and safety tasks (i.e., providing input to medical/safety protocol deviations, responses to medical/safety questions raised by Ethics Committees or Health Authorities or medical review of coding of adverse events in a trial)
• Support global pharmacovigilance and other department audits and inspections when required related to medical safety
• Create and maintain controlled medical safety documents (e.g., SOPs)
• Perform other medical safety related activities as assigned

Requirements:

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to Ophthalmology preferred.
• Direct patient care experience preferable
• A minimum of 3 years in medical safety/clinical
• At least 3 years of relevant clinical trial experience
• Knowledge of GCP (Good Clinical Practice) and other clinical trial regulations, knowledge of global pharmacovigilance regulations
• Excellent command over English language (written and verbal)
• Strong analytical and critical thinking skills
• Excellent communication and interpersonal skills
• Ability to manage multiple tasks/projects simultaneously
• Must be available during USA time zone working hours