Senior Specialist, Regulatory & PV Network

Senior Specialist, Regulatory & PV Network at Ergomed in Bosnia and Herzegovina

What This Role Involves

The Senior Specialist, Regulatory and PV Network is responsible for developing strategy based on regulatory requirements and driving regulatory and PV deliverables. They will act as a liaison between the regulatory team and other functional areas, including external partners, clients, authorities, and/or consultants. The role involves planning, organizing, and preparing regulatory deliverables following project, corporate, and industry regulatory strategies.

The Senior Specialist will also serve as the Local Contact Person for Pharmacovigilance for the designated country. They are expected to assume leadership and functional representation for projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables while driving the team to meet agreed targets and comply with procedures, trackers, and templates.

Core Duties

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Asume leadership and functional representation for projects of medium/high complexity
• Ensure effective coordination and management of regulatory deliverables
• Drive the team to meet agreed targets and comply with procedures, trackers, and templates
• Develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs, core documents) with a senior member of the team's help
• Provide strategic input to internal and external customers
• Promptly identify and address any risks or potential risks by implementing preventive measures
• Solve problems and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track, and maintain LCPs' CVs, job descriptions, training records, contact details, and monthly reports
• Ensure correct training assignment to and compliance by the LCPs
• Monitor project budgets, hours spent vs budgeted, and promptly identify issues

What You Bring

A relevant academic background in a related field is required. Experience as a Senior Specialist or similar role within the pharmaceutical industry is highly desirable. Strong leadership skills, excellent communication abilities, and the ability to work effectively with cross-functional teams are essential. Proficiency in project management tools and regulatory compliance standards is necessary.

More About Ergomed

Ergomed is a global contract research organization (CRO) dedicated to delivering high-quality clinical services. Our mission is to support our clients in achieving their therapeutic goals through innovative, reliable, and ethical solutions. We pride ourselves on fostering an inclusive work environment where creativity, collaboration, and integrity are valued.

How to Apply

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