Patient Safety Science Lead
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Patient Safety Science Lead (Pharmacovigilance): Providing safety-scientific expertise for development and marketed products with an accent on proactive safety surveillance, risk management, and benefit-risk assessment. Focus on leading global safety portfolios, influencing cross-functional stakeholders, and ensuring compliance with global PV regulations.
Location: Must be based in Europe (Remote or Hybrid options available).
Salary: From €68,500 (based on Italian market).
Company
is an international research-focused biopharmaceutical group and certified B Corp dedicated to developing innovative drugs and promoting a healthier world.
What you will do
- Develop and execute safety science strategies for assigned development and marketed products.
- Conduct proactive safety surveillance and risk management activities aligned with regulatory expectations.
- Collaborate with cross-functional teams including Clinical Development, Medical Affairs, and Regulatory Affairs.
- Provide safety input for clinical development plans, protocols, and regulatory submissions.
- Develop Health Hazard Assessments for quality complaints and manufacturing deviations.
- Represent the company as a subject matter expert during regulatory inspections and audits.
Requirements
- Advanced degree in Life Science, Pharmacy, or Medicine (PhD preferred).
- Minimum 8 years of experience in patient safety, including at least 6 years in safety science within pharma or CRO.
- Proven leadership experience managing global teams and complex safety portfolios.
- Expertise in global PV regulations, inspections, and cross-functional governance.
- Experience across multiple product modalities such as small molecules and biologics.
- Must be based in Europe to fulfill the role requirements.
Nice to have
- Experience with drug/device combination products.
- Strong background in crisis leadership and issue resolution.
Culture & Benefits
- Comprehensive healthcare programs and private medical insurance.
- Flexible working arrangements and remote work options.
- Annual bonus scheme based on performance.
- Pension scheme and wellbeing programs.
- Robust relocation support and tax assistance for foreign colleagues.
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