ICON plc is renowned for its commitment to innovation and excellence in clinical research and healthcare solutions. With a focus on creating an inclusive environment, ICON empowers employees to make meaningful contributions to clinical development. Joining ICON means being part of a global team that is dedicated to improving patient outcomes.
Responsibilities of a Pharmacovigilance Reporting Associate
In this dynamic role, your responsibilities will include:
- Submitting Serious Adverse Event (SAE) reports, periodic reports, and safety information to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within specified timelines.
- Managing safety reporting intelligence and ensuring timely and accurate communication with various parties.
- Overseeing projects to ensure compliance with ICON standards, regulatory requirements, and contractual obligations.
- Supporting departmental activities such as quality reviews, training oversight, and CAPA implementation.
- Maintaining project databases and ensuring documentation readiness for audits and inspections.
- Collaborating with cross-functional teams and fostering strong relationships with internal and external stakeholders.
- Staying updated on regulatory changes and safety reporting practices.
Qualifications and Skills Required
- A background in pharmacovigilance, clinical research, or related fields is desirable.
- Strong understanding of regulatory guidelines and safety reporting systems.
- Excellent organizational, analytical, and problem-solving skills.
- Effective communication and the ability to collaborate in a team environment.
- Willingness to travel (approximately 10%) domestically or internationally as needed.
Benefits of Working at ICON
ICON is dedicated to fostering a supportive and rewarding work environment. As a Pharmacovigilance Reporting Associate, you’ll enjoy:
- Competitive salary and benefits tailored to support work-life balance and well-being.
- Access to health insurance, retirement planning, and wellness programs.
- Opportunities for personal and professional growth through diverse career pathways.
- A commitment to diversity, inclusion, and belonging in the workplace.
- A chance to work with a global leader in clinical research, making a real impact on healthcare.
