Pharmacovigilance System Master File (PSMF) Sr. Specialist (M/F/D)

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‑orientated working style.

Requirements:

Start: 17.8.

Duration: 12 months

Capacity: 5 days per week

Location: Hybrid – approximately 80% + onsite presence in Greater Munich area