Senior Specialist, Regulatory & PV Network

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

📋 Description

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

• Lead and represent functional areas for projects of medium to high complexity, ensuring effective coordination and management of regulatory deliverables while driving the team to achieve agreed targets and adhere to established procedures, trackers, and templates.

• Collaborate with a senior team member to develop strategies and manage setup activities, including the Project Management Plan, joint operating procedures, Plans of Action (POAs), and core documents.

• Offer strategic insights to both internal and external clients, promptly identifying and addressing any risks or potential issues through the implementation of preventive measures.

• Troubleshoot and facilitate the resolution of performance issues or delivery failures.

• Collect, review, track, and maintain the CVs, job descriptions, training records, contact information, and monthly reports of Local Contact Persons (LCPs).

• Ensure proper training assignments and compliance with training requirements for LCPs.

• Guarantee that all team members assigned to the project are informed of their tasks and the time allocated, while monitoring project budgets and hours spent versus budgeted time, promptly identifying and escalating any out-of-scope (OoS) issues.

• Assist in the development of proposals and provide input for budgets, representing the department in Business Development meetings as necessary.

• Prepare client invoices and review or approve vendors’ project invoices.

• Offer training, coaching, and mentoring to junior staff members.

• Cultivate professional relationships with internal and external contacts at both local and international levels to ensure smooth and efficient service delivery.

• Stay updated on changing regulatory legislative requirements and ensure the maintenance of the regulatory intelligence database, disseminating relevant changes in a timely manner.

• Participate in and/or support junior members in preparing for audits and inspections, representing the department for assigned projects as needed.

• Monitor LCPs' key performance indicators and compile monthly summary reports.

• Provide feedback on vendor performance to assist in their evaluation.

• Contribute to department and company initiatives, aiding in the design and review of Standard Operating Procedures (SOPs), working practices, and guidance documents.

⛳️ Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.

• Significant experience in the pharmaceutical, Contract Research Organization (CRO), or regulatory sectors.

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

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

• Proficient in English, both written and spoken.

• The candidate must be fluent in the official language of the country in which they are based, as this is vital for local interactions and compliance.

• Proficiency in German, French, or Italian is advantageous but not essential.

• Strong planning and organizational abilities.

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

• Keen attention to detail.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional growth.

• A friendly and supportive work environment.

• The chance to collaborate with colleagues from around the globe, with English as the company’s primary language.