7 дней назад
GRAPS Patient Safety Operations, Post Marketing Manager (Pharmacovigilance)
46 000 - 57 500€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GRAPS Patient Safety Operations, Post Marketing Manager (Pharmacovigilance): Leading post-marketing pharmacovigilance operations and safety data collection across a global pharmaceutical portfolio with an accent on data quality, regulatory compliance, stakeholder coordination, and vendor oversight. Focus on inspection readiness, GVP audits, reconciliations, CAPA implementation, and continuous improvement of global Patient Safety processes.
Location: Parma, Italy; flexible hybrid working arrangement
Salary: €46,000–€57,500 per year, plus annual bonus eligibility and benefits.
Company
is an international research-focused biopharmaceutical group operating in more than 30 countries, developing and marketing innovative medicines across multiple therapeutic areas.
What you will do
- Lead post-marketing pharmacovigilance operations across the global product portfolio.
- Oversee collection, assessment, reconciliation, quality, compliance, and timely reporting of safety data.
- Supervise literature monitoring, company-sponsored websites, apps, social media, CROs, vendors, and Pharmacovigilance Service Providers.
- Act as a subject-matter expert for procedures, training, safety agreements, electronic AE/ADR reporting, and PSMF documentation.
- Support GVP audits and inspections, including preparation, auditor interviews, follow-up actions, and CAPA implementation.
- Drive process improvement and collaboration with Safety Science, Case Management, affiliates, and other R&D stakeholders.
Requirements
- Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline.
- Solid Pharmacovigilance Operations experience in a pharmaceutical, biotechnology, or healthcare environment.
- Strong knowledge of global pharmacovigilance regulations, GVP requirements, and post-marketing safety processes.
- Experience managing safety data collection, data quality, compliance, reporting, vendors, and service providers.
- Experience supporting audits, inspections, or compliance activities in a regulated environment.
- Professional proficiency in English, written and spoken, is required.
Nice to have
- Advanced knowledge of ODCS and literature monitoring, medical device and combination product vigilance, and global matrix organizations.
- Experience with safety agreements, CRO oversight, PV quality systems, deviations, CAPAs, and inspection readiness.
- Familiarity with safety databases, digital PV solutions, emerging technologies, and outsourced operating models.
- Project or change management experience in a regulated environment.
Culture & Benefits
- International, research-focused environment with a strong emphasis on sustainability, transparency, ethics, and inclusion.
- Flexible hybrid working arrangements and remote work options.
- Comprehensive benefits including pension, private medical insurance, wellbeing programs, and flexible benefits.
- Development resources, training opportunities, work-life balance initiatives, and tax assistance for foreign colleagues.
- Relocation support is available.
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