Senior Specialist, Regulatory & PV Network

This is a fully remote position, open to applicants in Poland.

📋 Description

• Formulate strategies in line with regulatory requirements and oversee regulatory and pharmacovigilance (PV) deliverables as per established timelines.

• Serve as the intermediary between regulatory and other functional departments, including external partners, clients, authorities, and consultants.

• Function as the Local Contact Person for Pharmacovigilance in the specified country.

• Lead and represent the organization for medium to high-complexity projects.

• Organize and manage regulatory deliverables while ensuring compliance with targets and processes.

• Create strategies and oversee setup activities with guidance from senior team members.

• Offer strategic insights and identify risks, implementing preventive measures as necessary.

• Resolve performance issues or failures in delivery through effective problem-solving.

• Collect, assess, monitor, and maintain Local Contact Person (LCP) CVs, job descriptions, training records, contact information, and monthly reports.

• Ensure appropriate training assignments and compliance for LCPs.

• Oversee project tasks, time allocation, budgets, and hours in relation to budget; escalate issues that fall outside the agreed scope.

• Assist in the development of proposals, budgets, and business development meetings.

• Prepare client invoices and review/approve vendor project invoices.

• Mentor, train, and coach junior staff.

• Cultivate professional relationships with internal and external stakeholders both locally and globally.

• Stay updated on changing regulatory requirements and maintain the regulatory intelligence database.

• Engage in or assist with audit/inspection preparations.

• Monitor LCP Key Performance Indicators (KPIs) and compile monthly summary reports.

• Provide feedback on vendor performance.

• Contribute to departmental and company initiatives while designing or reviewing Standard Operating Procedures (SOPs), working practices, and guidelines.

⛳️ Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or a related field.

• Significant experience in the pharmaceutical or Contract Research Organization (CRO) sector, or within a regulatory body.

• Strong understanding of ICH Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GVP), as well as national regulations relevant to the areas of expertise.

• PV training and/or relevant work experience along with other educational or professional qualifications as mandated locally.

• Proficient in English, both written and spoken.

• Competent in the official language of the country of residence.

• Strong organizational and planning abilities.

• Excellent interpersonal skills, especially in a fast-paced, deadline-driven, and dynamic environment.

• Keen attention to detail.

🏝️ Benefits

• Flexible remote work options.

• Opportunities for professional growth.

• A collaborative and supportive work atmosphere.

• Access to training, coaching, and mentoring opportunities.

• Join a passionate, collaborative team of experts.

• Contribute to professional development through the creation of SOPs, working practices, and guidelines.

• Collaborate with global teams across Europe, North America, South America, Asia, and Australia.