20 часов назад
Senior Manager, Drug Safety Physician
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
Senior Manager, Drug Safety Physician (Pharmacovigilance): Evaluating medicinal product safety data throughout the product lifecycle with an accent on individual case review, signal detection, benefit–risk assessments, and regulatory safety submissions. Focus on supporting the EU/UK QPPV, communicating with health authorities, and leading cross-functional medical safety activities.
Location: Hybrid work model in Warsaw, Masovian, Poland
Company
is a global MedTech company developing vital organ therapies, digital solutions, and advanced services, with a long-standing focus on kidney care.
What you will do
- Perform medical reviews of serious and non-serious individual case safety reports from clinical trials, post-marketing sources, literature, and partners.
- Conduct coding, causality and expectedness assessments, and provide clinical interpretation in line with global regulations and internal timelines.
- Participate in signal detection, validation, prioritization, documentation, and risk mitigation recommendations.
- Lead or support benefit–risk evaluations and provide medical input to PSURs, RMPs, and safety-related clinical documents.
- Contribute to regulatory safety submissions, health authority responses, core safety documents, inspections, and audits.
- Provide medical safety expertise across clinical, regulatory, medical affairs, quality, epidemiology, and commercial functions, while supporting the EU/UK QPPV.
Requirements
- Broad understanding of the global pharmacovigilance environment and relevant GVP, ICH, EMA, MHRA, FDA, and other global regulations.
- Strong analytical, problem-solving, clinical judgment, and benefit–risk assessment skills.
- Experience collaborating with Quality Assurance, Medical Affairs, Clinical, Medical Information, Regulatory Affairs, Sales, and Marketing functions.
- Leadership experience managing and developing staff, including teams working across geographic distances.
- Ability to communicate with health authorities and healthcare professionals and present pharmacovigilance and benefit–risk topics to regulators.
- Excellent oral and written communication in English.
Culture & Benefits
- Three-month probation period followed by an indefinite employment period.
- Private medical care, life insurance, Multisport card, annual and holiday bonuses, and a newborn baby bonus.
- Monthly benefit platform allowance of PLN 300, holiday co-financing, and two additional days off annually.
- Fully covered language courses and co-financing for corrective glasses and lenses.
- PPE program available after three months, referral bonus, and an additional birthday day off.
- Warsaw office located in Powiśle.
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