Senior Pharmacovigilance Associate

As a Senior Pharmacovigilance Associate at ICON Strategic Solutions, you will work in a sponsor-dedicated model supported by ICON's global expertise.

You will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities.

Key Responsibilities:

• 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.

Your Profile:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• 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.
• Willingness to travel as required (approximately 15%).

Rewards & Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.