PSMF Senior Specialist

Join a high-impact globalisation project where your PSMF expertise will help strengthen pharmacovigilance compliance across international markets.

R&D Partners is seeking a PSMF Senior Specialist to provide expert consulting services for a Pharmacovigilance System Master File (PSMF) globalization project. This role requires a detail-oriented professional with extensive experience in pharmacovigilance and PSMF processes.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Monitor and report on project deliverables, ensuring timelines are met.
• Review and update SOPs and develop guidance documents.
• Create training materials and deliver expert training sessions related to PSMF processes and requirements.
• Prepare and maintain monthly PSMF updates.
• Perform independent quality reviews of PSMF content and communicate required corrections to contributors.
• Provide expert consultation on CAPA measures arising from PSMF process audits.

Key Skills and Requirements:

• In-depth knowledge of regulatory requirements concerning the PSMF.
• Strong communication skills, excellent attention to detail, and ability to interact with multiple stakeholders across all levels.
• Minimum of a life sciences degree.
• At least 6 years of experience in pharmacovigilance, specifically handling the PV System Master File.
• Familiarity with EU regulations governing PV and global PSMF requirements.
• Proficiency in Word and Excel for generating and reviewing data listings.

For more information, please contact William Tyler.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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