Medical Director – Senior Medical Director, Nephrology

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Oversee all medical components of contracted tasks throughout the pharmaceutical product life-cycle.

• Ensure that tasks assigned to Pharmacovigilance (PV) are executed correctly while adhering to relevant regulations and ICH guidelines related to clinical trials, regulatory documents, and safety matters.

• Follow client Standard Operating Procedures (SOPs) and project-specific Work Process Documents (WPDs) for designated projects.

• Abide by CRG’s corporate policies along with SOPs and WPDs.

• Offer medical consultation to team members and address all study-related medical inquiries.

• Maintain clear communication with associates and clients, ensuring that all procedures are followed appropriately.

• Provide therapeutic and protocol training on assigned studies as needed.

• Assist in the writing (interpretation of safety and efficacy data) and/or reviewing Clinical Study Reports (CSR), IND/NDA reports, Individual Case Safety Reports (ICSR), signal detection reports, periodic reports, Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS), Common Technical Document (CTD) modules, etc., to ensure the accuracy and completeness of medical content.

• Monitor all safety variables (Adverse Events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) during clinical studies.

• Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) that arise during a study, applying sound medical judgment in interpreting and making decisions regarding clinical situations related to the investigational study.

• Conduct medical reviews of adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites.

• Perform data reviews as outlined in the client contract and data validation manual, including the review of coding listings and/or full safety data to identify potential safety concerns.

• Manage signal detection activities, scientifically evaluate aggregate reports, contribute to label updates, and support dossier maintenance and risk management initiatives.

• Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as per the contract.

⛳️ Requirements

• MD or equivalent degree is required.

• Active medical licensure is preferred.

• Clinical experience in treating patients in the specialty or sub-specialty aligned with the applicant's training (approximately 2 years).

• Relevant clinical trial experience within a Contract Research Organization, pharmaceutical company, or as a principal investigator (approximately 1-2 years) in the industry.

• Direct experience in safety/Pharmacovigilance (approximately 2 years).

• Knowledge, Skills, Abilities:

• Therapeutic expertise in one or more medical specialties or sub-specialties.

• Strong decision-making, problem-solving, organizational, and analytical skills.

• Excellent oral and written communication abilities.

• Working knowledge of pertinent safety databases (e.g., MedDRA).

• Willingness to travel domestically and internationally.

• Capability to work independently, analyze tasks with attention to detail, and process and prioritize complex sensitive information.

• Proficient in basic computer applications.

• Fluent in both spoken and written English.

• Exceptional interpersonal, influencing, and team-building skills.

• Understanding of guidelines (FDA, ICH, EMA, and GCP).

• Working knowledge of biostatistics, data management, and clinical operations procedures.

• Ability to serve as a mentor/trainer to other staff within Pharmacovigilance.

🏝️ Benefits

• Thermo Fisher Scientific prioritizes the health and well-being of its employees.

• We promote and support individuals in creating a healthy and balanced environment in which they can thrive.