Full-Time Senior Specialist Regulatory PV

Senior Specialist, Regulatory and Pharmacovigilance is responsible for developing strategy based on regulatory requirements and driving regulatory and Pharmacovigilance (PV) deliverables based on an established plan.

Serves as a liaison between regulatory and other functional areas (external partners, clients, authorities, and/or consultants) in planning, organizing, and preparing regulatory deliverables following project, corporate, and industry strategies.

Acts as Local Contact Person (LCP) for Pharmacovigilance in the designated country.

Job Responsibilities:

• Act as LCP for Pharmacovigilance in the designated country.
• Lead and represent projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables.
• Develop strategy and manage project set up activities (Project Management Plan, joint operating procedures, POAs, core documents).
• Provide strategic input to internal/external customers, identify risks/potential risks and implement preventive measures.
• Support 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 and training compliance for LCPs.
• Monitor project budgets, hours spent, and promptly escalate any out-of-scope (OoS) issues.
• Support proposal development and input to budgets, representing the department in BD meetings.
• Prepare client invoices and review/approve vendor invoices.
• Provide training, coaching, and mentoring to junior staff.
• Foster professional relationships with internal/external contacts.
• Stay updated on regulatory legislative changes and maintain the regulatory intelligence database.
• Participate in/support junior members in audits/inspections, representing the department as required.
• Track LCPs' key performance indicators and prepare monthly summary reports.
• Provide feedback on vendor performance for assessment.
• Provide input to department/company initiatives and contribute to SOPs/working practices.

Qualifications:

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent.
• Strong experience in pharmaceutical or CRO industry or regulatory body.
• Good knowledge of ICH GCP and/or GVP and national regulations.
• PV training and/or experience, and other relevant educational/professional background.
• Fluent in English, written and verbal.
• Proficient in the official language of the country.
• Proficiency in German, French, or Italian (optional).

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