ICON plc is a leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. With a global presence and commitment to inclusivity, ICON fosters an innovative environment that drives excellence in patient care and research. Whether working on clinical trials or utilizing cutting-edge technologies, ICON is at the forefront of healthcare, making a difference every day.
Job Description: Pharmacovigilance Reporting Associate
Location: Chennai, India
Time Type: Full-Time
Job Requisition ID: JR125423
We are looking for a passionate and detail-oriented Pharmacovigilance Reporting Associate to join our team. In this role, you will play a crucial part in ensuring the safety of clinical trial participants by managing the reporting of serious adverse events (SAEs) and other safety information.
Key Responsibilities:
- Safety Reporting: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, and applicable safety information to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within specified project timelines.
- Oversight and Compliance: Maintain oversight of assigned projects to ensure compliance with ICON’s Standard Operating Procedures (SOPs) and regulatory requirements.
- Collaboration: Work closely with project team members, clients, investigators, and third-party vendors to build and maintain effective relationships.
- Documentation: Perform filing and quality control of documents, ensuring that all safety-related documents are ready for audits or inspections.
- Training and Mentorship: Coach and mentor less experienced associates to enhance team competency in safety reporting practices.
- Travel: Be prepared for approximately 10% domestic and/or international travel as required.
Required Qualifications:
- Bachelor’s degree in a life science or related field.
- Previous experience in pharmacovigilance or clinical research is preferred.
- Strong understanding of safety reporting systems and regulatory compliance.
- Exceptional attention to detail and organizational skills.
- Ability to work in a collaborative team environment.
Why Work at ICON?
ICON values the contributions of its employees and offers a variety of benefits designed to promote well-being and work-life balance. Here are some reasons to consider joining ICON plc:
- Competitive Salary: Receive a competitive salary that reflects your skills and experience.
- Comprehensive Health Insurance: Choose from a range of health insurance options to meet the needs of you and your family.
- Retirement Planning: Access competitive retirement savings plans to prepare for your future.
- Employee Assistance Programme: Benefit from 24-hour access to specialized professionals who can support you and your family’s well-being.
- Flexible Benefits: Take advantage of country-specific benefits like childcare vouchers, gym memberships, and health assessments.