At ICON, our people are our greatest asset. Our diverse teams enable us to be a better partner to our customers and help us fulfill our mission to advance and improve patients’ lives. Our culture, driven by Accountability & Delivery, Collaboration, Partnership, and Integrity, sets us apart as an organization. We aim to be the Clinical Research Organization that delivers excellence to our clients and patients at every touchpoint, becoming the partner of choice in drug development.
Senior Pharmacovigilance Reporting Associate
Location: Chennai, Trivandrum
Job Requisition ID: JR116190
Department: Drug Safety ICON Full Service & Corporate Support
Work Type: Hybrid (Office/Remote)
About the Role:
As a Senior Pharmacovigilance Reporting Associate, you will play a critical role in ensuring the safety and efficacy of drugs by managing the submission and reporting of safety information. Your responsibilities will include:
- Safety Reporting:
- Submit expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings, and other safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, and ICON personnel within project-specified timelines.
- Release safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines.
- Knowledge and Compliance:
- Maintain a comprehensive understanding of ICON’s safety reporting systems, processes, and conventions.
- Understand and adhere to ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.
- Project Oversight:
- Oversee assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or the release of global safety reporting intelligence requirements.
- Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or intelligence on assigned projects.
- Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
- Support and Collaboration:
- Support the Safety Reporting Group management in all aspects of departmental activities, including quality and compliance metric review, finance tracking, project resource tracking, client engagement, training oversight, and CAPA oversight.
- Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units.
- Database Management and Quality Control:
- Work within multiple databases, maintaining project information or Pharmacovigilance intelligence information with timely updates.
- Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
- Training and Mentorship:
- Coach and mentor less experienced associates in all aspects of safety reporting or intelligence and other work as needed.
- Client and Internal Engagement:
- Participate in client and internal meetings, representing the Safety Reporting department for assigned projects.
- Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to clients and authorities, review of project requirements and maintenance activities, and budget considerations as assigned.
- Travel:
- Travel approximately 10% domestic and/or international as required.
- Other Duties:
- Perform other activities as identified and requested by management.
Qualifications:
- Experience:
- Relevant experience in pharmacovigilance and safety reporting.
- Skills:
- Excellent analytical and problem-solving skills.
- Strong oral and written communication skills in English.
- Good organizational and interpersonal skills; experience in a dynamic team environment.
- Technical Knowledge:
- Proficiency in safety reporting systems and processes.
- Knowledge of ICON SOPs, WPs, and regulatory requirements.
- Education:
- Degree in life sciences, pharmacy, or a related field.