Associate Director, Safety Physician (Medical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Associate Director, Safety Physician (Medical): Providing medical leadership for patient safety across clinical development and post-marketing with an accent on medical review, signal detection, and benefit–risk assessment. Focus on ensuring global regulatory compliance, proactive risk management, and cross-functional collaboration with clinical and regulatory teams.
Location: Onsite in Barcelona / Sant Feliu de Llobregat, Spain
Company
A global medical dermatology company dedicated to transforming patients' lives by addressing unmet needs through innovation and independent thinking.
What you will do
- Lead medical review of individual and aggregate safety data and chair safety review meetings.
- Oversee signal detection and evaluation, recommending proactive risk minimization actions.
- Author and review key safety documents including DSURs, PBRER/PSURs, and RMPs.
- Advise on clinical protocol safety design, stopping rules, and Data Monitoring Committee interactions.
- Ensure pharmacovigilance compliance and maintain inspection readiness with vendors and affiliates.
- Engage with health authorities to provide medical expertise and safety communications.
Requirements
- MD degree with clinical experience required.
- 8–10+ years of experience in pharmacovigilance or drug safety.
- Deep knowledge of ICH E2, GVP, and global safety regulations.
- Strong clinical judgment and cross-functional leadership capabilities.
- English proficiency required.
Nice to have
- Board certification in a relevant medical specialty.
- Experience with health authority interactions and regulatory inspections.
- Therapeutic area experience aligned with dermatology portfolio.
- Background in both clinical development and post-market safety.
Culture & Benefits
- Recognized as a Top Employer in Spain and Germany.
- Environment focused on independent thinking, ownership, and impact.
- Commitment to professional growth and career development.
- Focus on innovation and addressing real patient needs.
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