Pharmacovigilance Reporting Associate

ICON plc

Jan 10, 2025

Job
Full-time
Junior, Mid & Senior Level
Research & Development
Healthcare
Chennai
Quick Apply

AI generated summary

You must have experience in SAE reporting, strong knowledge of safety systems and SOPs, project oversight skills, database management, and the ability to collaborate and mentor others.
You will submit safety reports, ensure compliance with timelines, maintain databases, support audits, mentor colleagues, collaborate with teams, and manage project activities. Travel may be required.

Requirements

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.

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.

FAQs

What is the main responsibility of a Pharmacovigilance Reporting Associate?

The main responsibility is to submit expedited Serious Adverse Event reports, periodic reports, line listings, and applicable safety information to clients and regulatory authorities within specified timelines.

What types of reports will I be responsible for submitting?

You will be responsible for submitting expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information.

Is there a requirement for travel in this position?

Yes, travel is required approximately 10% of the time, which may include domestic and/or international travel.

Will there be opportunities for professional development in this role?

Yes, you will have opportunities to coach and mentor less experienced associates and participate in training oversight.

What kind of support does ICON provide for employees' well-being?

ICON offers a range of health insurance options, a Global Employee Assistance Programme, and various annual leave entitlements to support employee well-being.

How will performance be measured in this role?

Performance will be measured based on the accuracy and timeliness of submitted safety reports, as well as adherence to ICON's standards and regulatory requirements.

Are there opportunities to collaborate with other professionals?

Yes, you will collaborate with various parties, including project team members, client contacts, investigators, and third-party vendors.

What will be the focus while preparing for audits and inspections?

You will focus on file readiness for audits or inspections and ensure compliance with ICON's Standard Operating Procedures and project requirements.

What types of documents will I be managing in this role?

You will be responsible for managing safety reporting documents and ensuring their filing and quality control in the eTMF or other agreed filing solutions.

Is there a strong emphasis on diversity and inclusion at ICON?

Yes, ICON is committed to fostering a diverse and inclusive environment and values a workforce free of discrimination and harassment.

ICON plc

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.