Ref #: 31866

Employment type: Permanent - Full-Time

Location: Berkshire, UK

Posted: 03-Sep-2021

Description

At ICON Clinical, within our Global Strategic Solutions Team, as part of a long running global Drug Safety/Pharmacovigilance partnership with a well known global pharma company, we are currently recruiting for an experienced Drug Safety Surveillance Specialist to join us during Q4 2021.

Position Summary

The primary purpose of this Surveillance Specialist position is to perform safety surveillance activities on behalf of Global Patient Safety (GPS) which will be focused on case review, including routine surveillance, and periodic reporting of the late lifecycle portfolio (i.e., products with more than 10 years marketed experience), specifically to authoring safety sections, perform analysis of safety data, and provide oversight of timelines and other contributing functional areas to ensure completion of periodic reports per regulatory guidelines

Responsibilities

- Effectively utilize available tools to perform assigned safety deliverables. Consult and collaborate with safety physicians and other appropriate personnel to effectively complete assigned safety deliverables. Communicate relevant safety information appropriately and in a timely manner.
- Author safety sections, perform analysis of safety data, and provide oversight of timelines and other contributing functional areas to ensure completion of periodic reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs) and Risk Management Plans (RMPs).
- Complete safety data analysis and authoring of safety sections for ad-hoc safety reports and routine surveillance purposes.
- Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.
- Adhere to requirements in quality system documents for assigned safety deliverables to ensure compliance with local laws and regulations.
- Understand and apply Global Patient Safety business practices
- Identify and act on internal process improvements in product safety standards and practices.

Requirements

- At least 3 years of experience in pharmaceutical industry or clinical setting, with demonstrated experience in Global Patient Safety, Pharmacovigilance, including prior experience in Safety Surveillance activities.
- Clinical knowledge of various disease states, drug effects, human physiology and pharmacology,
- Effective communication skills to interact with diverse groups and individuals,
- Demonstrated ability to provide risk-based decision making in a regulated environment
- Knowledge of global regulations with respect to drug safety case management.
- Knowledge and understanding of global patient safety policies and procedures

This is a unique opportunity to work for the world leading FSP provider (ICON GSS), in partnership with a Top pharma company, within an embedded model, working alongside some of the SMEs in within the DS/PV space. We offer competitive compensation packages, flexible working, career development opportunities among others.

Please note that we can consider only those applicants that are authorized to work in UK and are currently based in the UK.

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.
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 provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.