Drug Safety Officer

Qualifications:

• Bachelor's degree in pharmacy or medicine
• At least 2 years’ experience within the pharmacovigilance departments in pharmaceutical industry or equivalent
• Background as a QPPV/QPPV deputy at European level is a plus
• Good understanding of EU and local pharmacovigilance regulations and guidelines
• Excellent written and oral communication skills in Romanian and English
• High level of accuracy and attention to detail

KEY RESPONSIBILITIES:

• Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system;
• Provide Pharmacovigilance training to MAGNAPHARM employees, customers and service providers as applicable, etc.
• Maintain awareness and ensure adherence to established and updated local processes and guidelines;
• Ensure PV business continuity and out of hours availability process.
• Lead and coordinate internal and external PV audits and inspections/self-inspections ( customer, service providers, local and EMA authorities)
• Monitor affiliates’ PV system performance and compliance.
• Be the main responsible person for the day-to-day pharmacovigilance activities: Individual case safety report management, PSUR submission cooperation, archiving, implementation of any local risk minimization measure, management and fulfillment of pharmacovigilance agreements, maintenance of updated local Standard Operating Procedures (SOP) in line with applicable regulations;