Senior Pharmacovigilance Associate

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

📋 Description

• Leading the collection, assessment, and processing of adverse event reports to guarantee timely and precise reporting in alignment with regulatory guidelines and company policies.

• Conducting comprehensive data analysis and interpretation of safety information, pinpointing trends and potential safety signals that necessitate further investigation.

• Preparing and submitting detailed periodic safety update reports (PSURs) and other regulatory documents, ensuring adherence to international regulations.

• Collaborating with medical and clinical teams to evaluate the clinical significance of reported adverse events and contribute to risk management initiatives.

• Overseeing the upkeep and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.

• Offering training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.

• Participating in audits and inspections conducted by regulatory authorities, ensuring preparedness and compliance with all pertinent pharmacovigilance requirements.

⛳️ Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.

• Extensive experience in pharmacovigilance or drug safety, with a robust understanding of relevant regulations and industry standards.

• Demonstrated ability to effectively manage the pharmacovigilance process, including adverse event reporting and signal detection.

• Strong analytical and critical thinking skills, with the capacity to interpret complex data and provide informed recommendations.

• Advanced proficiency in English.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.