4 дня назад
Safety Manager (Pharmacovigilance)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Safety Manager (Pharmacovigilance): Managing drug, biologics, and medical device surveillance programs, clinical trial safety, post-marketing activities, and Country Quality Plans with an accent on adverse event processing, regulatory compliance, and inspection readiness. Focus on leading safety projects, coordinating resources and stakeholders, and solving complex reporting and compliance challenges across local and international requirements.
Location: Oslo, Norway; hybrid work arrangement
Company
develops medicines and supports evidence-based medical and safety decision-making to improve patient health outcomes.
What you will do
- Monitor and manage surveillance programs for drugs, biologics, and medical devices, including adverse event intake, evaluation, and processing.
- Support clinical trials and post-marketing activities while maintaining safety and regulatory compliance.
- Lead or co-lead moderately complex safety projects, managing timelines, resources, forecasts, and process improvements.
- Oversee the Country Quality Plan and guide colleagues in adverse event report processing.
- Collaborate with internal and external stakeholders and act as a subject matter expert for Safety Evaluation and Reporting.
- Manage safety resources, complete safety reports, and support audits, regulatory inspections, and inspection readiness.
Requirements
- BA/BS with at least 4 years of experience, MBA/MS with at least 2 years, PhD/JD with any experience, or equivalent experience based on the stated education pathways.
- Experience in pharmacovigilance, data management, clinical care, or scientific research.
- Strong understanding of pharmaceutical business, drug development, regulatory requirements, and international reporting obligations.
- Strong organizational, time management, problem-solving, and decision-making skills.
- Computer literacy, particularly experience managing relational databases.
- Fluency in spoken and written English and Norwegian is required.
Nice to have
- Master's degree and relevant pharmaceutical industry experience.
- Managerial experience in a hospital or pharmacy and familiarity with clinical assessment.
- Knowledge of training design, training tools, and training methodology.
- Experience collaborating with cross-functional teams and strong analytical skills.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with knowledge of responsible AI, risk management, and ethical use.
Culture & Benefits
- Hybrid work arrangement.
- Inclusive workplace supporting diversity, accessibility, and equal employment opportunities.
- Reasonable adjustments are available to support candidates with disabilities.
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