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Operation Specialist 1 (Pharmacovigilance)
Описание вакансии
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TL;DR
Operation Specialist 1 (Pharmacovigilance): Processing and reviewing safety data, adverse events, and case information for clinical research projects with an accent on regulatory compliance, accurate database entry, and quality standards. Focus on coding adverse events and products, writing narratives, maintaining safety cases, and supporting medical review of non-serious adverse events.
Location: Reading, Berkshire, United Kingdom
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Process safety data and information according to applicable regulations, SOPs, guidelines, and project requirements.
- Collect, track, assess, and maintain adverse event and endpoint information, including initial and update status determination.
- Enter and code cases in safety databases, write narratives, and perform literature-related activities within project timelines.
- Create, maintain, and track safety cases while meeting quality, productivity, delivery, and compliance standards.
- Identify quality issues, support problem solving, and collaborate with project management, clinical, data management, healthcare professionals, and clients.
- Depending on project requirements, perform medical review of non-serious adverse events and adverse drug reactions, including coding, medical history, concomitant medications, expectedness, and causality assessments.
Requirements
- High school diploma or equivalent in a scientific, healthcare, or allied life sciences discipline; a bachelor's degree in life sciences or a related field is relevant.
- Up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience, or an equivalent combination of education, training, and experience.
- Working knowledge of medical terminology, safety databases, internal or client applications, and applicable clinical research regulations.
- Strong attention to detail, accuracy, organization, time management, communication, and problem-solving skills.
- Ability to follow guidelines, work independently and as part of a team, manage competing priorities, meet strict deadlines, and adapt to changing processes.
- Flexibility to work in shifts; occasional travel may be required.
Culture & Benefits
- Structured training plans, required SOP training, and documented training transcripts.
- Opportunities to learn skills across safety service lines and mentor less experienced team members when assigned.
- Participation in project team meetings and department initiatives.
- Collaboration with cross-functional teams, healthcare professionals, and clients.