Drug Safety Associate
Posted 1 day ago by Arriello Group
- Industry Pharma/Biotech/Clinical Research
- Remote Job
This is a remote position.
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.
At Arriello, our values define how we work - and who we are:
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.
Innovative - We collaborate closely-with our clients, colleagues and partners-to proactively find better ways forward.
Passionate - We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
About the RoleAs a Global Drug Safety Associate, you will support the delivery of high quality clinical and post marketing safety activities. You will work closely with senior Drug Safety colleagues to process safety cases, maintain documentation, and support compliance and operational tasks across multiple projects.
Key Responsibilities- Support the processing of safety cases from clinical trial and post marketing sources, including AEs, SAEs, and SUSARs.
- Assist with case receipt, triage, data entry, MedDRA and WHO Drug coding, follow up activities, and quality checks within safety databases.
- Support expedited and local ICSR submissions under supervision.
- Assist with reconciliation of safety data with clinical databases.
- Support global and local literature monitoring activities.
- Maintain and update Drug Safety documentation, trackers, and project files in line with internal procedures.
- Provide administrative and operational support to the Global Drug Safety team, including mailbox monitoring and document management.
- Support compliance monitoring, reporting activities, and internal process adherence.
- Collaborate with cross functional teams and external partners as required.
- Bachelor's degree in pharmaceutical sciences, life sciences, medicine, or a related field.
- At least one year of experience in a Drug Safety, Pharmacovigilance, or medical environment.
- Exposure to safety case processing in clinical trial and or post marketing settings is highly desirable.
- Basic understanding of Drug Safety regulations and guidelines, including ICH, GVP, GCP, and CIOMS.
- Experience or familiarity with safety databases is an advantage.
- Fluent written and spoken English.
- Strong attention to detail, organizational skills, and willingness to learn.
- A collaborative team player with a positive and proactive attitude.
- Work remotely while contributing to a global life sciences consultancy .
- Lead quality operations that directly influence patient safety and regulatory compliance.
- Collaborate in a multicultural, inclusive, and innovative environment.
- Enjoy opportunities for career progression, professional development, and international exposure.
- Flexible Work Options : Remote working flexibility to support your lifestyle.
- Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
- Home Office Support: Get support to create a productive home office setup.
- Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
Arriello is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity. We encourage applicants from all backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national origin, or any other characteristic protected by law.
In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at .