Senior Safety Scientist

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.

ICON is seeking a Senior Safety Scientist to join their team and assist with the ongoing workload supporting their Global client and working closely with client’s MDs.  Ideally, previous experience will include, but is not limited to, the following therapy areas: 

Rare Diseases, Hematology, Gastrointestinal, Diabetes, Hypertension, Internal Medicine, ADHD, Oncology, Surgical Patches, Wound Healing, Parkinson’s Disease, Pain Management. 

Responsibilities for the Senior Safety Specialist role are:

Activities includes post-marketing signal detection and signal management, input and review of risk management plans, aggregate safety reports, support of regulatory requests and global and local labeling.

Signal Detection, Evaluation, and Management:

• Perform proactive safety monitoring and signal detection for marketed products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation.
• Complete initial assessment of safety signals and prepare draft interpretation of reviewed data for assessing safety signals.
• Evaluates and prepares documents to answer internal and/or external requests on safety data including the IB, labeling, aggregate reports, and regulatory submissions.
• Plan and execute literature surveillance as needed

Risk Management Plans:

• Review of RMP/REMS including aRMMs and provide input as needed
•  Risk Management Activities for post-approval of core/designated core and EU RMPs

Periodic (Aggregate) Safety Reporting:

• Provides input and review for aggregate reports for submission to the health authorities and other stakeholders, as needed. Specifically, PBRERs, PADERs, ACOs, local safety summary reports, etc.

Additional Responsibilities:

• Review of Regulatory Authority Websites as pertaining to signal information
• Review of Local Labeling USPI & SmPC
• Responsible for responses to Health Authorities’ requests and responses to inquiries from internal and external customers.

Basic Requirements:

• Scientific or Healthcare background (RN, PharmD, PhD)
• Minimum 3 years relevant pharmaceutical/biotech industry experience as PV Scientist including at least 5 years’ experience in Pharmacovigilance
• Safety Surveillance, specifically post marketing signal detection and risk management experience
• Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations and Good Pharmacovigilance (GVP)
• Working knowledge of ARGUS
• Working knowledge of MedDRA coding's
• This role is a remote opportunity

Professional Competencies:

• Good time management skills, able to prioritise workload accordingly
• Complies with all relevant safety and GxP procedures 
• Ability to work independently to manage safety responsibilities and as part of a team

• #LI-MO1
• #LI-Remote

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 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 through the form below.

Salary Range:

$136,300-$163,570 USD

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.   You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Visit our careers site to read more about the benefits ICON offers.