4 дня назад
Operations Specialist Mgr (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Operations Specialist Mgr (Pharmacovigilance): Processing and overseeing safety data, adverse event cases, regulatory reports, and pharmacovigilance operations for clinical research projects with an accent on compliance, quality, and project delivery. Focus on leading operational workflows, mentoring team members, coordinating regulatory reporting, and solving cross-functional safety process issues.
Location: Dublin, Ireland
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Review, assess, process, and track safety data and adverse event information across pharmacovigilance service lines.
- Enter and maintain cases in safety databases, code adverse events and products, write narratives, perform quality reviews, and support reconciliation and case closure.
- Assess cases for reportability and coordinate expedited submissions to regulatory authorities, ethics committees, investigators, and oversight groups.
- Set up and maintain safety reporting procedures, project files, templates, electronic forms, databases, and workflows.
- Provide operational oversight for small to medium projects and act as a functional lead on larger projects when required.
- Mentor and train junior staff, monitor project metrics and productivity, and collaborate with project management, clinical, data management, clients, and healthcare professionals.
Requirements
- Bachelor’s degree in a scientific, healthcare, or allied life sciences discipline, or an equivalent combination of education, training, and experience.
- Up to 5 years of relevant experience, including up to 3 years of pharmacovigilance experience.
- In-depth knowledge of safety databases, internal or client applications, and applicable global, regional, and local clinical research regulations.
- Excellent knowledge of medical terminology, organizational skills, attention to detail, and ability to meet strict deadlines.
- Project management, leadership, mentoring, coaching, problem-solving, and delegation skills.
- Strong written and verbal communication skills with the ability to work independently and across multiple projects.
Culture & Benefits
- Collaborative environment focused on quality, compliance, productivity, and delivery standards.
- Opportunities to participate in training, working groups, and process improvement initiatives across safety service offerings.
- Structured training plans with required SOP training and maintained training transcripts.
- Regular collaboration with operational teams, project stakeholders, clients, and healthcare professionals.
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