Drug Safety Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The purpose of the ICON Drug Safety Associate is to perform a broad range of activities to manage adverse event collection, processing and reporting activities on behalf of the client Global Patient Safety Team.

Delivery

• Perform tasks within assigned functional area team, building proficiency to meet targets for delivery and client expectations.
• Demonstrated understanding of the documented processes and conventions applicable to scope of own assigned activities.
• Growing understanding of the legislative requirements for activities performed.

Quality and compliance

• Delivers quality and compliance in line with documented procedures and expectations, including those in program performance measures.
• Able to take steps to avoid late reporting and non-compliance. Contribute to investigations for corrective and preventative action plans.
• Aware of importance of own role and able to define where it fits into the wider department organisation with awareness of up and downstream activities.
• Aware of the QPPV role and their responsibilities.
• Supports inspection readiness through own activities and aware of why audits/inspections are conducted.
• Aware of the departmental Business Continuity Plan and when it may be implemented.

Tasks are determined by assigned functional area team and allocated on a rotational basis. All activities are performed in line with the client's documented processes and conventions. The following are considered core team tasks for each work stream; additional responsibilities may be assigned across the groups as appropriate and at the discretion of ICON and client management.

Safety Management:

• Handling and data entry of Individual Case Safety Reports (ICSRs) from different receipt sources and therapeutic areas.
• Expedited Safety Reporting to Regulatory Authorities (EMA, MHRA, HPRA).
• Provide operational support to Country Affiliates.

UK Affiliate, Operations Team:

• Receipt, triage, and initial data entry of Individual Case Safety Reports (ICSRs) from different receipt sources in line with documented processes and conventions.
• Expedited and Aggregate Safety Reporting to Ethics Bodies.
• Own partner relationships for collection of adverse event information (including Patient Support Programs (PSP), Market Research, Medical Information, Digital Media, Third Party Organisations (TPOs)).
• Maintain and update EMA master data repositories.

UK Affiliate, Periodics Team:

• Prepare and maintain the periodic reporting calendar, communicating amendments to key stakeholders (Medical Organisation, Safety Management, Central Regulatory Registry, Global Affiliates) as appropriate
• Distribute periodic safety reports to global publishing team and global affiliates in an efficient and timely manner to ensure regulatory compliance
• Record, monitor, and tracking periodic safety report submissions to EMA and Regulatory Authorities
• Ensure on-time exchange and tracking of periodic safety reports and Risk Management Plans with business alliance partners
• Communicate effectively with internal and external business partners to ensure outputs and reports comply with global procedures
• Adhere to quality systems requirements, and maintain tracking systems / procedure documentation