PV Project Specialist

We are looking for a PV Project Specialist with proven experience in pharmacovigilance and excellent management skills. This is a key role in the organization, involving the management of supplier interactions, updating procedures, overseeing safety reports, and ensuring compliance with strict regulatory requirements.

What will you do in this role?

• Manage daily activities with pharmacovigilance suppliers and track schedules.
• Periodically update PSMF (Pharmacovigilance System Master File) documents and approve them.
• Implement pharmacovigilance audit strategies and plans.
• Write and update SOPs (Standard Operating Procedures) according to updated regulations and guidelines.
• Manage Safety Data Exchange Agreements (SDEAs) and ensure compliance with mutual requirements.
• Train staff in pharmacovigilance and manage training documentation.
• Review regulatory changes and coordinate relevant updates with other departments in the organization.
• Supervise the preparation of periodic safety reports (PBRERs, DSUR) and oversee their submission.

Job Requirements:

• Bachelor's degree in Pharmacy, Life Sciences, Biology, Biotechnology, or a related field – mandatory.
• At least two years of experience in the pharmaceutical industry in similar roles (pharmacovigilance/regulation).
• High-level proficiency in English (spoken and written).
• Proven project management skills and ability to meet tight deadlines.
• Proficiency in Office applications.