Position: Senior Pharmacovigilance Reporting Associate
Location: Chennai, India (Hybrid: Office/Remote)
Company Overview:
ICON plc is a leading global healthcare intelligence and clinical research organization. Our commitment to fostering an inclusive environment and driving innovation positions us at the forefront of clinical development. We invite you to join us as we work together to improve patients’ lives and advance the future of healthcare.
Role Overview:
We are seeking a Senior Pharmacovigilance Reporting Associate for our Chennai office. This hybrid role involves managing the submission of safety reports, maintaining compliance with ICON’s standards and regulatory requirements, and providing support to the Safety Reporting Group.
Key Responsibilities:
Safety Reporting: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and applicable safety information to clients, regulatory authorities, ethics committees, and investigators within project timelines.
Project Oversight: Ensure all safety reporting activities meet ICON, sponsor, and regulatory deadlines. Operate in a lead capacity, taking ownership of assigned projects and safety reporting tasks.
Compliance: Maintain up-to-date knowledge of ICON’s safety reporting systems, Standard Operating Procedures (SOPs), and guidance documents. Ensure project activities adhere to regulatory and client requirements.
Quality and Documentation: Oversee the quality and filing of documents submitted to the eTMF or other filing solutions. Prepare for audits and inspections, ensuring project readiness.
Team Support and Development: Provide support and mentorship to less experienced associates in safety reporting. Implement and coordinate project activities, including presentations at meetings and responses to stakeholders.
Collaboration: Work with project team members, client contacts, investigators, and third-party vendors to build and maintain relationships. Manage project information across multiple databases and maintain accurate updates.
Travel: Be prepared for approximately 10% domestic and/or international travel as required.
Qualifications:
Benefits of Working at ICON:
Equal Opportunity Employer:
ICON is committed to providing a workplace free of discrimination and harassment. We ensure all qualified applicants receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Accommodations:
If you require a reasonable accommodation due to a medical condition or disability during the application process or in order to perform the essential functions of the position, please let us know.
Interested?
If you’re passionate about making a difference and meet the qualifications, we encourage you to apply. Even if you’re unsure about meeting all the requirements, we welcome your application.
Current ICON Employees:
Please click here to apply.
Explore more about our benefits and the impact you can make by visiting our careers site.
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