Clinical Safety Scientist

2 weeks ago

Dublin, Ireland Arriello Group Full time

Overview
Pharmacovigilance Specialist - Clinical Safety (Remote)
Industry: Pharma/Biotech/Clinical Research • Location: Remote
About Arriello
At Arriello, we provide a full range of Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies.
With a team of experienced professionals, we support our clients in meeting their regulatory obligations, maintaining product quality and patient safety, and navigating complex global compliance landscapes.
As a growing business with a dynamic culture, we are committed to high-quality delivery, continuous improvement, and creating an environment where people can thrive.
Values
Inclusive
We value equity, inclusion and dignity for all, recognising that we learn from each other every day.
Dedicated
We challenge the status quo to deliver pragmatic, tailored solutions for our clients.
We collaborate closely—with our clients, colleagues and partners—to proactively find better ways forward.
We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
Main Purpose of the Role
As a Clinical Safety Scientist, you will play a pivotal role in ensuring the safety and compliance of clinical trials for our esteemed clients.
The position executes project-related tasks and activities and can delegate activities to other team members within the unit (PV Associates and Assistants) as required and ensures high quality of the services provided.
Key Responsibilities
Execute various project tasks related to End to End Clinical Safety Management, including but not limited to authoring Safety Management Plans and reviewing Clinical Safety documents.
Core operational tasks include:
Manage safety-related aspects of clinical trials, including SAE processing and QC, SUSAR reporting, and Safety Data Reconciliation.
Ensure compliance with regulatory requirements (ICH, GVP, GCP, CIOMS).
Requirements
Degree in pharmaceutical sciences or related fields (advanced degree or significant relevant experience preferred).
3+ years of experience in clinical safety processing.
In-depth knowledge of drug safety regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.).
Proven experience working within safety databases.
Skilled in reviewing and validating work completed by colleagues, ensuring high standards of accuracy and compliance.
Meticulous attention to detail, with a commitment to accuracy and compliance.
Soft Skills:
Strong analytical and problem-solving skills, excellent English written and verbal communication, and the ability to work effectively in cross-functional teams are vital.
Benefits
Flexible remote working options.
Generous time off: 5 weeks of holiday plus national holidays and 3 personal days.
Home office support to create a productive setup.
Bonuses: annual bonus program, spot bonuses, and employee-nominated recognition.
Equal Opportunity
Arriello is an Equal Opportunity Employer.
We are committed to a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity.
We encourage applicants from all backgrounds and may provide accommodations during the hiring process.
If you require accommodation, please contact ******.
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