Senior Pharmacovigilance Associate

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

📋 Description

• Lead the gathering, assessment, and processing of adverse event reports in alignment with regulatory standards and company procedures.

• Perform data analysis and interpretation of safety information, recognizing trends and potential safety signals.

• Prepare and submit periodic safety update reports (PSURs) along with other regulatory documents.

• Collaborate with medical and clinical teams to evaluate the clinical significance of adverse events and contribute to risk management efforts.

• Supervise the upkeep and integrity of pharmacovigilance databases.

• Provide training and mentorship to junior team members.

• Participate in regulatory audits and inspections, ensuring compliance and preparedness.

⛳️ Requirements

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

• Extensive experience in pharmacovigilance or drug safety, with a solid comprehension of applicable regulations and industry standards.

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

• Strong analytical and critical thinking abilities, with the capacity to interpret intricate data and provide sound recommendations.

• Excellent communication and interpersonal skills, with the proficiency to work collaboratively within cross-functional teams.

• Proficiency in pharmacovigilance databases and data management systems, in addition to the Microsoft Office Suite.

• Ability to work autonomously and juggle multiple priorities in a dynamic environment.

• Willingness to travel as necessary (approximately 15%).

• Legal authorization to work in Chile.

🏝️ 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.