[Hiring] Freelance Senior Pharmacovigilance Associate @ICON plc

Role Description

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.

What You Will Do:

• Take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
• Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
• Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
• Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
• Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
• Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
• Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.

Qualifications

• 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%).

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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.
• Benefits may vary depending on role and location.

Company Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.