Pharmacovigilance Specialist

DeltaPv İlaç Danışmanlık Sağlık Ürünleri ve Hiz.Tic. Ltd Şti.

Job Description

• Responsible for the compliant and timely operational delivery of assigned project activities within defined scope, quality standards, and regulatory requirements.
• Acts as Primary or Secondary Project Responsible, ensuring clear ownership, accountability, and continuity of project-related activities.
• Ensures that all activities within company responsibility are performed in compliance with the contracted Scope of Work (SOW), applicable regulatory requirements (e.g., GVP, local regulations), and the company and/or client quality systems.
• Ensures timely identification and escalation of risks impacting compliance, patient safety, project delivery, business continuity, or client relationship, in line with internal escalation procedures.
• Supports the Project Manager in execution of project strategy and provides input on operational planning, including resource needs, workload distribution, and budget impact.
• Acts as Subject Matter Expert (SME), contributing to the development, review, and continuous improvement of procedures, policies, and systems.
• Maintains up-to-date knowledge of applicable global and local pharmacovigilance regulations, including EMA GVP, ICH guidelines, and relevant local authority requirements.
• Participates in audits, inspections, and quality investigations, supporting CAPA development and implementation, and ensuring continuous inspection readiness.
• Provides pharmacovigilance expertise and operational guidance to project teams, including mentoring and coaching where applicable, ensuring consistent and compliant execution of activities.
• Supports development, review, and delivery of pharmacovigilance training materials and ensures completion of assigned training in accordance with training plans and regulatory expectations.
• Maintains awareness of project budget, contracted scope, and expected effort per task, and communicates deviations or additional requirements to line management in a timely manner.
• Identifies resource requirements at project or country level and escalates to project management; participates in recruitment and onboarding processes where required.
• Ensures delivery of operational performance in line with defined KPIs and project objectives.
• Contributes to business development, marketing, and operational efficiency initiatives, where applicable.
• Performs additional tasks as assigned in line with company needs and contractual obligations.

Role Qualifications

• A Pharmacy degree (Mandatory)
• Excellent written and oral communication skills in English and Turkish (Mandatory)
• At least 1 year of PV experience is preferred
• Experience in pharmaceutical companies is an advantage.
• Exposure to healthcare/life-sciences industry is an advantage.

Expected skills

• Exceptional analytical and quantitative problem-solving skills.
• Well-organized personality with attention to details.
• Ability to work under pressure and urgent deadlines.
• Strong planning and reporting skills.
• Demonstrated track record of innovative thinking.
• Ability to develop and interpret policies and to perform multiple tasks.
• Ability to work as an assistant for a team.