Senior Pharmacovigilance Associate

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Assume responsibility for pharmacovigilance and drug safety outcomes.

• Direct 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.

• Offer training and guidance to junior team members.

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

⛳️ Requirements

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

• Significant experience in pharmacovigilance or drug safety, with a comprehensive understanding 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 skill to interpret complex data and provide informed recommendations.

• Exceptional communication and interpersonal skills, with the capacity to collaborate across cross-functional teams.

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

• Ability to work autonomously and juggle multiple priorities in a fast-paced setting.

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

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-based 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 advancement pathways.