3 дня назад
Senior Pharmacovigilance Consultant, Alliance Management (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Pharmacovigilance Consultant, Alliance Management (Pharmacovigilance): Managing LPPV networks, pharmacovigilance system master files, safety data exchange agreements, and alliance management services for biotech, medical device, and pharmaceutical clients with an accent on regulatory compliance, vendor oversight, and stakeholder coordination. Focus on maintaining compliant PV documentation, negotiating safety agreements, supporting audits and inspections, and improving alliance management processes.
Location: Leiden, Netherlands. Remote working is supported; hybrid work is encouraged for new hires within a reasonably short commute of a office.
Company
provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.
What you will do
- Coordinate and oversee Local Contact Person Responsible for Pharmacovigilance (LPPV) networks, including vendor oversight, performance management, stakeholder engagement, and PV governance support.
- Set up and routinely update Pharmacovigilance System Master Files (PSMFs) and associated annexes.
- Serve as an LPPV and maintain alliance management processes for client engagements.
- Draft, review, and negotiate Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Services Agreements (PVSAs), and Statements of Work.
- Draft and review Pharmacovigilance Management Plans and support client audits and inspections.
Requirements
- BSc or higher in life sciences or an industry-related discipline.
- At least 4 years of clinical or post-marketing pharmacovigilance experience.
- At least 2 years of alliance management experience.
- Thorough understanding of the PV and regulatory landscape within the UK and EU.
- Strong written and oral communication, negotiation, planning, prioritization, decision-making, and problem-solving skills.
- Ability to manage multiple projects and collaborate effectively with clients and internal teams.
Culture & Benefits
- Remote working is supported, with hybrid collaboration encouraged where practical.
- Inclusive workplace focused on diversity, equity, and inclusion.
- Environment that encourages innovation, collaboration, and entrepreneurship.
- Applications are personally reviewed by the recruitment team without AI screening tools.
- Applicants receive an outcome on their application.
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