ICON plc is a globally recognized healthcare intelligence and clinical research organization committed to innovation and excellence. With a strong focus on fostering an inclusive and collaborative work environment, ICON is dedicated to improving clinical development processes and ensuring patient safety. The company specializes in various domains, including clinical research, pharmacovigilance, and regulatory affairs, helping pharmaceutical and biotechnology companies bring safe and effective products to market.
Responsibilities in the Job
As a Pharmacovigilance Associate, you will play a critical role in monitoring and maintaining the safety profile of pharmaceutical products. Your primary responsibilities include:
- Collecting and reviewing adverse event reports to ensure accurate and timely documentation in compliance with regulatory guidelines.
- Conducting signal detection and risk assessments to identify potential safety concerns.
- Collaborating with cross-functional teams to support safety-related investigations and inquiries.
- Staying updated with the latest pharmacovigilance regulations and industry best practices.
- Assisting in the preparation of safety reports and regulatory submissions.
- Maintaining high standards of quality and compliance in all pharmacovigilance activities.
Qualifications Required
To be considered for the role of Pharmacovigilance Associate at ICON, candidates should meet the following criteria:
- A Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Advanced degrees preferred).
- Prior experience in pharmacovigilance, drug safety, or a related domain within a clinical or pharmaceutical environment.
- A strong understanding of pharmacovigilance regulations and industry standards.
- Analytical skills with a keen eye for detail in reviewing safety data and reports.
- A commitment to patient safety and regulatory compliance.
Key Skills Required
To excel in this role, candidates should possess:
- Analytical and problem-solving skills to assess drug safety data effectively.
- Excellent communication and interpersonal skills for seamless collaboration with internal and external stakeholders.
- Attention to detail to ensure compliance with safety regulations and guidelines.
- Ability to work in a fast-paced environment while managing multiple tasks efficiently.
- Proficiency in regulatory documentation and pharmacovigilance software.
