Drug Safety Associate

2 weeks ago

Reading, United Kingdom ICON Full time

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center 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.

**Please note, this position will require two days per week in the office in Berkshire.**

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 sponsor'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 sponsor 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.

**Professional competencies**
- Communicates clearly and effectively verbally and in written formats in a variety of settings
- Demonstrated ability to prioritise workload and complete all deliverables by deadlines set
- Escalates issues effectively and proposes potential solutions based on own experiences
- Makes informed experienced based decisions, and has awareness of own remit of authority
- Builds and maintains relationships within functional area team to work collaboratively
- Demonstrated ability to receive and appropriately act upon feedback. Able to provide constructive feedback regarding processes and delivery.
- Adheres to confidentiality guidelines and expectations with an understanding of how to identify and protect company information
- Displays integrity

**Minimum**
- Effective communication skills (written and verbal), fluent in English
- Proficient in Microsoft Office suite
- Knowledge of medical terminology
- Excellent organisational and time management skills with proven ability to prioritise and manage multiple deliverables
- Detail orientated
- Effectively respond to requirements and requests.

**Preferred**
- Knowledge of global regulations with respect to pharmacovigilance.
- Knowledge of medical coding systems.
- Ability to work autonomously, influencing without authority, ability to network ideas in corporate environment.
- Ability to learn quickly and adapt to a changing environment.
- Flexibility to adapt to changing priorities.
- Demonstrated interpersonal skills.
- Ability to see the big picture; use logic to solve problems.

**Educational requirements**
- Bachelor’s degree (or higher) in a healthcare-related or life science field
- Demonstrated equivalent experience

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to

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