Pharmacovigilance Jobs at Icon Plc: Apply Now for Reporting Associate Role

Icon Plc Hiring Pharmacovigilance Reporting Associate

Icon Plc is a leading Clinical Research Organization (CRO) committed to advancing and improving patients’ lives. Our diverse teams embody our core values of Accountability & Delivery, Collaboration, Partnership, and Integrity. As a partner in drug development, we aim to deliver excellence at every touchpoint, making us the preferred choice in the industry.

Pharmacovigilance Reporting Associate

Company Name: Icon Plc

Salary: Competitive salary packages with annual bonuses reflecting performance goals.

Company Address: Chennai, Trivandrum

Detailed Job Description

As a Pharmacovigilance Reporting Associate, you play a pivotal role in the pharmaceutical industry, ensuring the accurate and timely reporting of adverse events associated with drugs. Your responsibilities encompass a range of tasks aimed at maintaining the safety and compliance of pharmaceutical products.

Job Responsibilities

• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines.
• Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures.
• Maintain a strong understanding of ICON’s safety reporting systems, processes, and conventions, as appropriate.
• Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
• Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
• Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
• Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
• Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
• Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units.
• Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
• 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.
• Prepare for and represent the department in audits and inspections as designated.
• Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned.
• Coach and mentor less experienced associates in safety reporting or safety reporting intelligence activities and other work, as needed.
• Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.
• Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects, as designated.
• Maintain understanding of applicable therapeutic areas and disease states as required.
• Travel (approximately 10%) domestic and/or international, as required.
• Perform other activities as identified and requested by management.

Qualifications and Skills:

• Bachelor’s degree in a relevant scientific or healthcare field.
• Understanding of pharmacovigilance principles, regulations, and guidelines.
• Strong attention to detail and organizational skills.
• Effective communication and collaboration skills.
• Familiarity with pharmacovigilance databases and reporting tools is advantageous.

Benefits of Working in ICON

Our success relies on the quality of our people. To reward high performance and nurture talent, we offer:

• Very competitive salary packages, regularly benchmarked against competitors.
• Annual bonuses reflecting the delivery of performance goals.
• Range of health-related benefits for employees and their families.
• Competitive retirement plans and related benefits such as life assurance.

Icon Plc as a PV Reporting Associate Apply online

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Careers