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Pharmacovigilance System Master File (PSMF) Senior Specialist (M/F/D)
Tasks:
Provide expert consulting services for global Pharmacovigilance System Master File (PSMF) initiatives.
Monitor project progress and ensure timely delivery of defined project milestones and deliverables.
Review, update, and optimize Standard Operating Procedures (SOPs) and develop supporting guidance documentation.
Create training materials and deliver expert training sessions related to PSMF processes and regulatory requirements.
Support the preparation, maintenance, and periodic updates of the Pharmacovigilance System Master File.
Perform independent quality reviews of PSMF content to ensure compliance with internal procedures and regulatory expectations.
Identify documentation gaps, communicate required corrections to relevant stakeholders, and support continuous quality improvements.
Provide expert guidance for the development and implementation of CAPA measures resulting from audits and process assessments.
Collaborate with cross-functional stakeholders to ensure accurate, complete, and compliant pharmacovigilance documentation.
Qualification:
University degree in Life Sciences or a related scientific discipline.
Approximately six years of professional experience in Pharmacovigilance with proven hands-on responsibility for the Pharmacovigilance System Master File (PSMF).
Strong knowledge of EU Pharmacovigilance regulations, particularly PSMF requirements; knowledge of global PSMF regulations is considered an advantage.
Experience reviewing highly regulated documentation with exceptional attention to detail.
Ability to work with Microsoft Word and Excel for data review, documentation, and reporting.
Strong communication and stakeholder management skills with the ability to collaborate across international and cross-functional teams.
Independent, structured, and quality-oriented working style.
Requirements:
Start: 17.8.
Duration: 12 months
Capacity: 5 days per week
Location: Hybrid – approximately 80% + onsite presence in greater munich area
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