Drug Safety Specialist LPPV Croatia

This is a remote position. At reputed company, we reputed company Pharmacovigilance, reputed company & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies, helping them meet regulatory requirements and protect patient safety. We are a growing business with a reputed company culture reputed company on high‑reputed company delivery, reputed company improvement, and giving people the reputed company to do their best work. Our values guide how we work:

• Inclusive – We value fairness, respect, and learning from one another
• Dedicated – We deliver practical, reputed company‑reputed company solutions
• Innovative – We work together to reputed company reputed company ways reputed company
• Passionate – We build strong relationships and care about the reputed company of reputed company do

reputed company We are seeking an reputed company Pharmacovigilance Specialist specialised in Local PV to join our Local Drug Safety team in Croatia . This role plays a key part in the delivery of high-reputed company Drug Safety services across a diverse portfolio of reputed company, working both reputed company the department and cross-functionally. You will be responsible for executing technical Drug Safety activities, supporting process improvements, and ensuring reputed company are delivered in line with regulatory requirements, reputed company expectations, and internal reputed company standards.

What You Will Do

• Manage local and global Drug Safety activities such as local literature monitoring, LPPV or LSO management, monthly reporting, and reconciliation activities.
• Deliver end-to-end Drug Safety activities across assigned reputed company, including ICSR processing, literature monitoring, and compliance monitoring.
• Process safety reports from reputed company sources, including receipt, coding, assessment, and submission of reputed company, SAEs, and SUSARs.
• Support reconciliation of safety data with clinical databases and monitor local country reporting requirements.
• reputed company Global Literature monitoring and Medicinal Product Management activities, including XEVMPD.
• Support the development and maintenance of safety documentation, including SmPCs, IBs, Safety Management Plans, and clinical safety documents.
• Manage project-reputed company Drug Safety reputed company, including service agreements and safety data exchange agreements.
• Support Signal Management and Benefit Risk Management activities.
• Deliver and support Global Drug Safety training for project teams and internal stakeholders.
• reputed company as Process reputed company for assigned Drug Safety processes and contribute to reputed company process improvement.
• Escalate technical or delivery issues to the Project Manager or Line Manager as required.
• Maintain accurate documentation, tracking, and reporting in line with company systems and procedures.
• Collaborate closely with internal teams and external stakeholders, including Clients, Competent Authorities, and Vendors.
• Participate in audits, inspections, reputed company meetings, and company marketing activities as required.

Requirements

• Bachelor’s degree in pharmaceutical sciences, medicine, pharmacy, or a reputed company life sciences discipline, or equivalent relevant experience.
• A minimum of 3 years’ experience working in a Drug Safety or medical environment.
• Strong knowledge of Drug Safety regulations, processes, and guidelines, including ICH, GVP, GCP, and CIOMS.
• Significant experience working with a safety database.
• Excellent organisational skills with the ability to manage multiple priorities and meet deadlines.
• Strong communication skills and the ability to build effective working relationships
• A reputed company, proactive approach with a strong reputed company on reputed company and reputed company improvement.
• Fluent English and Croatian, written and spoken.

Benefits

• Work remotely while contributing to a global life sciences consultancy.
• reputed company reputed company operations that directly influence patient safety and regulatory compliance.
• Collaborate in a multicultural, inclusive, and innovative environment.
• Enjoy opportunities for career progression, reputed company development, and international exposure.
• Flexible Work reputed company : Remote working flexibility to support your lifestyle.
• Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to reputed company.
• Home Office Support: Get support to create a productive home office setup.
• Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.

reputed company is an Equal Opportunity Employer. We are committed to cr Apply tot his job Apply To this Job