Senior Specialist, Regulatory & PV Network

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

📋 Description

• Serve as the Local Contact Person for Pharmacovigilance within the assigned country.

• Lead and represent functional aspects of medium to high complexity projects, ensuring effective coordination and management of regulatory deliverables, and guiding the team to meet established targets while adhering to agreed procedures, trackers, and templates.

• Collaborate with a senior team member to formulate strategies and manage setup activities, including the Project Management Plan, joint operating procedures, POAs, and core documents.

• Offer strategic insights to both internal and external stakeholders, swiftly identifying and mitigating any risks or potential risks through the implementation of preventive measures.

• Resolve problems and assist in achieving satisfactory outcomes for performance issues or delivery failures.

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

• Ensure appropriate training assignments and compliance for LCPs.

• Make sure all project team members are aware of their tasks and allocated time, monitor project budgets, hours worked versus budgeted time, and quickly identify and escalate any out-of-scope (OoS) issues.

• Assist in proposal development and budget input, and represent the department at Business Development meetings as necessary.

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

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

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

• Stay updated on evolving regulatory legislative requirements, maintaining the regulatory intelligence database and ensuring timely dissemination of relevant changes.

• Participate in and/or support junior team members in audit/inspection preparations and represent the department for assigned projects as required.

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

• Provide feedback on vendor performance to facilitate their assessment.

• Contribute to department and company initiatives and assist in the design and review of SOPs, working practices, and guidance.

⛳️ Requirements

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

• Significant experience within the pharmaceutical or CRO industry, or a Regulatory body.

• Strong understanding of ICH GCP and/or GVP, as well as national regulations relevant to the areas of responsibility.

• PV training and/or relevant working experience, along with any other educational or professional background as required locally.

• Proficient in English, with strong verbal and written communication skills.

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

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

• Excellent planning and organizational abilities.

• Strong interpersonal skills in a dynamic, deadline-driven environment.

• Exceptional attention to detail.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive working atmosphere.

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