Director, Medical Safety
iqvia · Zagreb
Opis radnog mjesta
About the role
The Director, Medical Safety will lead global medical safety oversight across clinical development and post‑marketing programs, ensuring high‑quality, compliant deliverables and supporting business growth.
Key responsibilities
- Conduct medical review of clinical trial and post‑marketing safety data, including AEs, ADRs, coding, causality, seriousness assessments and benefit‑risk evaluations.
- Provide medical oversight of safety documentation such as narratives, aggregate reports, annual safety reports, risk management plans and regulatory submissions.
- Support safety governance activities including Data Safety Monitoring Boards, Safety Monitoring Committees and 24‑hour medical support.
- Lead or serve as Global Safety Physician, ensuring quality, compliance, training, stakeholder communication and timely delivery.
- Present safety findings and offer expert medical consultation to clients and cross‑functional teams.
- Manage and develop medical safety teams through people management, workload planning, performance management and succession planning.
- Oversee financial, operational and quality performance of projects, ensuring appropriate resourcing and regulatory compliance.
- Contribute to business development activities such as proposals, budgeting, client presentations and service‑line growth initiatives.
Required profile
- Medical degree (MD or equivalent) with substantial clinical practice or pharmaceutical physician experience.
- Current medical licensure (or equivalent professional registration) in the country of practice.
- Significant experience in medical safety, pharmacovigilance or medical monitoring within pharma, biotech, CRO or healthcare.
- Strong knowledge of global pharmacovigilance, clinical research, safety reporting, GCP and applicable regulatory requirements.
- Proven leadership capability, including people management, project oversight, financial accountability and strategic decision‑making.
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iqvia
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