QPPV & Medical Advisor

Adamco Pharm

Essential Duties and Responsibilities:

• Develop and maintain expert knowledge of pharmaceutical product safety and efficacy.
• Review clinical study data and assess safety-efficacy profiles.
• Analyze preclinical and clinical data for medicinal products.
• Maintain current knowledge of product indications and contraindications.
• Understand product mechanisms of action and pharmacology.
• Assess product safety in diverse patient populations.
• Support medical decisions on product positioning and use.
• Review clinical trial data and study protocols.
• Assess methodology and safety aspects of clinical studies.
• Analyze safety data from clinical trials.
• Support statistical analysis and epidemiological assessments.
• Provide medical input to regulatory submissions.
• Monitor relevant scientific literature and medical journals.
• Retrieve and analyze medical information on products and therapeutic areas.
• Respond to medical information inquiries from HCPs.
• Provide accurate and balanced medical information.
• Support evidence-based decision-making with scientific data.
• Establish and maintain a functional and compliant pharmacovigilance system.
• Develop and implement pharmacovigilance standard operating procedures (SOPs).
• Design processes for adverse event collection, assessment, and reporting.
• Create systems for signal detection and risk management.
• Develop quality assurance procedures for PV activities.
• Document and maintain the Pharmacovigilance System Master File (PSMF).
• Oversee all components of the company's PV system including database operations.
• Conduct periodic reviews of PV system functionality and compliance.
• Perform pharmacovigilance audits and inspections.
• Identify and resolve system deficiencies through corrective and preventive actions (CAPAs).
• Ensure validation status and data integrity of PV databases.
• Maintain and update PSMF to reflect current PV system.
• Oversee PV activities conducted by third parties (distributors, CROs, service providers).
• Manage contractual arrangements for outsourced PV functions.
• Ensure third-party compliance with company PV standards.
• Conduct audits of third-party PV operations.
• Maintain oversight of all external data sources.br>