Senior Specialist, Regulatory and Pharmacovigilance

Senior Specialist, Regulatory and Pharmacovigilance

3 days ago Be among the first 25 applicants

Company Description

PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-lasting relationships and being a global leader in its field. We cover all therapy areas, including medical devices. We invest in our staff through excellent training and development, valuing employee experience, well-being, and work-life balance to foster high-quality client service. Join us in making a positive impact on patients' lives.

Job Description

The Senior Specialist, Regulatory and PV Network, develops strategies based on regulatory requirements and drives regulatory and PV deliverables according to established plans. Acts as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and consultants, in planning, organizing, and preparing regulatory deliverables. Serves as the Local Contact Person for Pharmacovigilance in the designated country.

Job Responsibilities

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Lead and represent projects of medium / high complexity, ensuring effective coordination and management of regulatory deliverables, meeting targets, and adhering to procedures
• Develop strategies and manage setup activities with senior team members (Project Management Plan, SOPs, POAs, core documents)
• Provide strategic input, identify risks, and implement preventive measures
• Support resolution of performance issues or delivery failures
• Maintain LCPs' CVs, job descriptions, training records, contact details, and reports
• Ensure proper training assignment and compliance for LCPs
• Monitor project budgets, hours, and escalate any issues
• Support proposal development, budgeting, and client meetings
• Prepare and review invoices
• Mentor junior staff and foster professional relationships
• Stay updated on regulatory changes and disseminate information
• Assist in audits / inspections and represent the department as needed
• Track KPIs and prepare reports
• Contribute to SOP and process improvements

Qualifications

Additional Information

We prioritize diversity, equity, and inclusion, creating an environment where all can contribute and grow. We offer training, career development, a supportive environment, and opportunities to work globally with English as the company language.

Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships. We look forward to your application.

J-18808-Ljbffr

J-18808-Ljbffr