Senior Pharmacovigilance Associate

Senior Pharmacovigilance Associate

ICON

Sofia, Bulgaria

We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

What You Will Be Doing:

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies;
• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation;
• Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations;
• Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities;
• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards;
• Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices;
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements;
• Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.

Your Profile:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred;
• Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards;
• Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection;
• Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations;
• Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams;
• Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite;
• Ability to work independently and manage multiple priorities in a fast-paced environment;
• Commitment to maintaining confidentiality and handling sensitive patient information with discretion.