обновлено 2 дня назад
Global R&D QA - Patient Safety Partner Compliance Specialist
46 000€
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
Global R&D QA - Patient Safety Partner Compliance Specialist (Pharmacovigilance): Ensuring the pharmacovigilance quality system complies with regulatory requirements and company quality standards with an accent on managing deviations, CAPAs, and PV QMS documentation. Focus on supporting audits/inspections, maintaining PSMF and PV systems, and developing PV QMS metrics/KPIs while coordinating with the QPPV interface.
Location: Parma (Italy); hybrid and predominantly remote options
Salary: €46,000 minimum
Company
International research-focused biopharmaceutical group with a global R&D footprint.
What you will do
- Manage pharmacovigilance deviations identified through compliance monitoring.
- Monitor CAPA implementation resulting from audits and deviations.
- Review PV System SOPs/WIs for compliance with applicable regulations and internal quality standards; draft PV QA SOPs/WIs.
- Support preparation, management, and follow-up of regulatory authority and partner inspections/audits.
- Collaborate on PV QMS data collection and development of metrics/KPIs; manage PV System changes.
- Update and maintain PSMF information and company PV QMS systems/tools, including supplier qualification status.
Requirements
- Degree in Life Sciences (Pharmacy, Biology, Medicine, Biotechnology, Chemistry or equivalent).
- 3–5 years in pharmacovigilance and/or QA in pharma.
- Hands-on experience with PV QMS (deviations, CAPA, change control) and SOP/WI writing/review.
- Strong knowledge of GVP/PV regulations (EMA/FDA) and understanding of PSMF and PV systems.
- Experience with quality systems and PV tools/databases; ability to manage compliance monitoring and metrics/KPIs.
- English: fluent.
Nice to have
- Experience in global/matrix pharma environment.
- Exposure to regulatory inspections (EMA/FDA) and audit/inspection support.
- Supplier qualification in PV.
- Knowledge of ICH guidelines.
Culture & Benefits
- Hybrid and predominantly remote working arrangements.
- Annual bonus scheme eligibility based on company and individual performance.
- Comprehensive benefits package including pension, private medical insurance, wellbeing and flexible benefits.
- Relocation support and tax assistance services for foreign colleagues.
Hiring process
- Interviews to assess experience with PV QMS, compliance monitoring, and stakeholder communication (including QPPV interface).
- Evaluation of fit for documentation/SOP work and inspection/audit support responsibilities.
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