обновлено 8 дней назад
PSMF & Compliance Manager (Pharmacovigilance)
46 000€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
PSMF & Compliance Manager (Pharmacovigilance): Supporting the global pharmacovigilance system by evaluating regulations, maintaining the PSMF, and monitoring compliance KPIs with an accent on regulatory applicability, stakeholder coordination, and system performance reporting. Focus on tracking metrics and trends, resolving compliance issues, and advising the QPPV on PSMF changes and amendments.
Location: Parma, Italy; based at the headquarters with a flexible hybrid working arrangement
Salary: Minimum €46,000 annually, plus an annual performance-based bonus.
Company
is an international research-focused biopharmaceutical group operating in more than 30 countries, with research and development activities across pharmacovigilance, clinical development, regulatory affairs, quality assurance, and related functions.
What you will do
- Support the global pharmacovigilance system in meeting regulatory requirements for structure and performance.
- Evaluate pharmacovigilance regulations, guidelines, and recommendations for applicability to the company’s PV system.
- Coordinate the timely collection of documentation and maintenance of the Pharmacovigilance System Master File (PSMF).
- Advise the QPPV and stakeholders on potential PSMF changes and amendments.
- Contribute to pharmacovigilance KPI definition, monitoring, evaluation, and reporting.
- Track metrics, trends, compliance issues, and resolutions, and prepare reports on global PV system performance.
Requirements
- Master’s degree in life sciences, pharmacy, or a related field.
- At least 5 years of international pharmacovigilance experience in the pharmaceutical, biotechnology, or contract research organisation sector.
- Experience supporting regulatory compliance and pharmacovigilance systems.
- Effective communication, decision-making, judgment, and problem-solving skills.
- Ability to work effectively in a team.
Culture & Benefits
- Flexible hybrid working arrangement.
- Annual bonus scheme linked to company and individual performance.
- Pension, private medical insurance, wellbeing programme, and flexible benefits programme.
- Development opportunities with access to resources and training.
- Relocation support, flexible working options, and tax assistance services for foreign colleagues.
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