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.
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