обновлено 3 дня назад
Patient Safety Science Lead (Pharmacovigilance)
68 500 - 94 000€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Patient Safety Science Lead (Pharmacovigilance): Leading safety surveillance, risk management, and safety-scientific assessments for development and marketed pharmaceutical products with an accent on predictive safety strategies, regulatory compliance, and benefit–risk decision-making. Focus on integrating global safety data, guiding cross-functional clinical and regulatory activities, and managing complex safety portfolios across development and post-approval stages.
Location: Europe (flexible) — remote or hybrid
Salary: Minimum €68,500 annual salary; final compensation, bonus, and benefits depend on the country of employment and applicable local market framework.
Company
Chiesi is an international research-focused biopharmaceutical group headquartered in Parma, Italy, operating in more than 30 countries with over 8,000 employees.
What you will do
- Lead safety-scientific strategy, surveillance, and risk management activities for assigned development and marketed products.
- Monitor and assess emerging safety profiles using all relevant data sources and support informed benefit–risk decisions.
- Integrate safety input into clinical development plans, protocols, study documents, and regulatory submissions.
- Develop health hazard assessments for quality complaints and manufacturing deviations within the GMP quality process.
- Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Quality, Safety Operations, partners, and external providers.
- Contribute to safety communications, inspections, audits, regulatory interactions, due diligence, licensing, acquisitions, and scientific innovation.
Requirements
- Advanced degree in Life Science, Pharmacy, Medicine, or a related scientific discipline; a relevant PhD is preferred.
- At least 8 years of general patient safety experience and 6 years of safety science experience in a pharmaceutical or CRO organization.
- Experience in post-marketing and clinical development safety, global pharmacovigilance regulations, inspections, and governance.
- Proven leadership of global teams and complex safety portfolios across early and late development and post-approval products.
- Experience with small molecules, biologics, drug/device combination products, and multiple therapeutic areas.
- Strong strategic judgment, crisis leadership, stakeholder influence, communication, analytical, planning, and organizational skills.
Culture & Benefits
- Purpose-driven culture focused on sustainable innovation, reliability, transparency, ethical behavior, and patient safety.
- Flexible working arrangements with remote work options.
- Annual performance-based bonus scheme.
- Benefits may include a company car, pension, private medical insurance, wellbeing programs, and flexible benefits.
- Healthcare programs, work-life balance initiatives, development resources, training, relocation support, and tax assistance for foreign colleagues.
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