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

📋 Description

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

• Ensure that tasks assigned to Pharmacovigilance (PV) are executed effectively.

• Offer medical guidance to team members and address all inquiries related to study-specific medical issues.

• Support in drafting (interpretation of safety and efficacy data) and/or reviewing Clinical Study Reports (CSR), Investigational New Drug/New Drug Application (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.

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

⛳️ Requirements

• MD or an equivalent qualification is required.

• Active medical licensure is preferred.

• Clinical experience in patient treatment within the specialty or sub-specialty relevant to the applicant's training (approximately 2 years).

• Relevant clinical trial experience in 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).