Specjalista / Specjalistka Ds. Bezpieczeństwa Farmakoterapii
Polpharma Group
Not specified; not specified; comprehensive benefi...
Hybrid
Psur report preparation and coordination
Risk management plan development and monitoring
Safety signal and adverse event analysis
Polpharma Group is seeking a Specialist in Pharmacovigilance to prepare, coordinate, and update PSUR reports, manage risk plans, and analyze safety data. The ideal candidate will have a higher education in medical, pharmaceutical, or biological sciences, with at least two years of relevant experience and a strong understanding of pharmacovigilance regulations
Job Summary
The role involves preparing, coordinating, and updating PSUR reports in accordance with regulatory requirements.
Candidates will develop, implement, and monitor risk management plans for medicinal products while analyzing safety data.
The company offers a modern work environment with remote work options, additional paid days off, and a comprehensive benefits package.
Matching Summary
Match Score: 85
Polpharma Group is seeking a Specialist in Pharmacovigilance to prepare, coordinate, and update PSUR reports, manage risk plans, and analyze safety data. The ideal candidate will have a higher education in medical, pharmaceutical, or biological sciences, with at least two years of relevant experience and a strong understanding of pharmacovigilance regulations.
Salary
Not specified; Not specified; Comprehensive benefits including private healthcare and Multisport card
Skills & Requirements
Must-have
PSUR report preparation and coordination
Risk management plan development and monitoring
Safety signal and adverse event analysis
Regulatory compliance with GVP ICH EMA FDA
Polish Pharmaceutical Law knowledge
Nice-to-have
Experience creating educational materials
Background in product registration processes
QPPV support or QPPV function experience
Advanced English language proficiency
Strong analytical and problem-solving skills
Key Requirements
Higher education in medical, pharmaceutical, or biological sciences
Minimum 2 years of experience in pharmacotherapy safety