Medical Director – Senior Medical Director, Cardiology

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

📋 Description

• Oversee medical aspects of clinical trials, ensuring adherence to company SOPs, client directives, good clinical practice, and regulatory standards.

• Participate in and deliver presentations at investigator and sponsor meetings.

• Offer medical consultation to clients, investigators, project teams, and colleagues.

• Assist in business development efforts.

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

• Ensure that pharmacovigilance-delegated tasks are executed correctly and comply with relevant regulations, ICH guidelines, client SOPs, project WPDs, and corporate policies.

• Provide therapeutic and protocol training for assigned studies.

• Draft or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related deliverables.

• Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests.

• Address medical concerns with principal investigators and clients, making informed medical decisions regarding clinical situations.

• Conduct medical reviews of adverse events of special interest, serious adverse events, and clinical outcome events.

• Perform data reviews and validate coding listings and complete safety data to evaluate potential safety issues.

• Manage signal detection efforts and scientifically evaluate aggregate reports.

• Contribute to label updates, dossier maintenance, and risk management initiatives.

• Review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.

⛳️ Requirements

• MD or equivalent degree is required.

• Active medical licensure is preferred.

• Clinical experience in the relevant specialty or sub-specialty equivalent to 2 years, or suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator equivalent to 1–2 years, or direct safety/pharmacovigilance experience equivalent to 2 years.

• A combination of relevant education, training, and/or directly related experience may be considered equivalent in some instances.

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

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

• Exceptional oral and written communication skills.

• Familiarity with relevant safety databases, such as MedDRA.

• Willingness to travel both domestically and internationally.

• Ability to work independently, analyze tasks attentively, and prioritize sensitive complex information.

• Proficiency in basic computer applications.

• Fluent in both spoken and written English.

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

• Knowledge of FDA, ICH, EMA, and GCP guidelines.

• Understanding of biostatistics, data management, and clinical operations procedures.

• Capability to mentor and train other pharmacovigilance staff.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Reasonable accommodation for individuals with disabilities.

• Benefits and privileges associated with employment.

• Chance to contribute to life-changing therapies and scientific advancements.