Role Description
This is a remote position.
As 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
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Support the processing of safety cases from clinical trial and post‑marketing sources, including AEs, SAEs, and SUSARs.
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Assist with case receipt, triage, data entry, MedDRA and WHO Drug coding, follow‑up activities, and quality checks within safety databases.
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Support expedited and local ICSR submissions under supervision.
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Assist with reconciliation of safety data with clinical databases.
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Support global and local literature monitoring activities.
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Maintain and update Drug Safety documentation, trackers, and project files in line with internal procedures.
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Provide administrative and operational support to the Global Drug Safety team, including mailbox monitoring and document management.
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Support compliance monitoring, reporting activities, and internal process adherence.
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Collaborate with cross‑functional teams and external partners as required.
Qualifications
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Bachelor’s degree in pharmaceutical sciences, life sciences, medicine, or a related field.
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1–3 years of experience in Drug Safety, Pharmacovigilance, or a medical environment, including case processing and regulatory submissions.
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Experience in safety case processing within both clinical trial and post‑marketing settings is required.
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Basic understanding of Drug Safety regulations and guidelines, including ICH, GVP, GCP, and CIOMS.
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Experience or familiarity with safety databases is an advantage.
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Fluent written and spoken English.
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Strong attention to detail, organizational skills, and willingness to learn.
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A collaborative team player with a positive and proactive attitude.
Benefits
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Work remotely while contributing to a global life sciences consultancy.
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Lead quality operations that directly influence patient safety and regulatory compliance.
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Collaborate in a multicultural, inclusive, and innovative environment.
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Enjoy opportunities for career progression, professional development, and international exposure.
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Flexible Work Options: Remote working flexibility to support your lifestyle.
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Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
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Home Office Support: Get support to create a productive home office setup.
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Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
Company Description
At Arriello, we provide Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies, helping them meet regulatory requirements and protect patient safety. We are a growing business with a collaborative culture focused on high‑quality delivery, continuous improvement, and giving people the space to do their best work.
Our values guide how we work:
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Inclusive
– We value fairness, respect, and learning from one another.
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Dedicated
– We deliver practical, client‑focused solutions.
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Innovative
– We work together to find better ways forward.
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Passionate
– We build strong relationships and care about the quality of what we do.
