Job title:pharmacovigilance reporting associate(icon plc)

Location:chennai,trivandram

Job Profile:

The role involves managing and overseeing safety reporting activities for clinical trials and post-market surveillance to ensure compliance with regulatory and client requirements. Key tasks include submitting Serious Adverse Event (SAE) reports, periodic safety reports, and safety information to stakeholders such as regulatory authorities, ethics committees, and investigators within established timelines.

Responsibilities also include maintaining expertise in ICON's safety systems, Standard Operating Procedures (SOPs), and guidance documents. The individual ensures project-specific safety reporting meets regulatory, client, and internal standards. Acting in a leadership capacity, the role involves ownership of safety reporting activities, mentoring junior staff, and collaborating with cross-functional teams.

Other duties include maintaining pharmacovigilance databases, preparing documentation for audits and inspections, and staying updated on regulatory changes. The role also involves participating in client and internal meetings, delivering presentations, and ensuring projects are audit-ready. Periodic travel and contributing to departmental operations such as training oversight, CAPA management, and resource tracking are also required.

This position requires a proactive approach to ensuring compliance, strong coordination with stakeholders, and a focus on delivering high-quality safety reporting services to support clinical development and post-market activities.