1 месяц назад
Director, Medical Safety (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Medical Safety (Pharmacovigilance): Providing global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs with an accent on safety data review, regulatory documentation, and benefit-risk assessments. Focus on leading medical safety teams, managing complex projects, ensuring regulatory compliance, and supporting client engagement and service-line growth.
Location: Zagreb, Croatia
Company
provides clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
What you will do
- Conduct medical review of clinical trial and post-marketing safety data, including adverse events, causality, expectedness, seriousness, coding, and benefit-risk evaluations.
- Provide medical oversight for safety documentation, aggregate reports, periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms.
- Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and medical support.
- Lead medical safety projects as a Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, delivery, training, and stakeholder communication.
- Lead and develop global teams of physicians and medical safety professionals through resource planning, performance management, mentoring, training, and succession planning.
- Oversee project financial and operational performance and contribute to proposals, budgeting, client presentations, strategic planning, and service-line growth.
Requirements
- Strong knowledge of global pharmacovigilance, clinical research, safety reporting, Good Clinical Practice, and applicable regulatory requirements.
- In-depth understanding of clinical development, pharmaceutical research, and medical safety and monitoring activities.
- Medical degree or equivalent from an accredited institution, with substantial clinical practice and/or pharmaceutical physician experience.
- Significant experience in medical safety, pharmacovigilance, or medical monitoring within the pharmaceutical, biotechnology, CRO, or healthcare industry.
- Current medical licensure or equivalent professional registration in the country of practice.
- Demonstrated leadership, consulting, communication, stakeholder management, project oversight, financial accountability, and strategic decision-making skills.
Culture & Benefits
- Work across global clinical development and post-marketing safety programs.
- Collaborate with clients, internal teams, and cross-functional stakeholders.
- Contribute to continuous improvement based on industry, regulatory, and pharmacovigilance developments.
- Support organizational objectives through external representation and strategic initiatives.
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