Senior Specialist, Regulatory & PV Network

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

📋 Description

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

• Take charge of leadership and functional representation for medium to high complexity projects, ensuring effective coordination and management of regulatory deliverables while driving the team to meet established targets and adhere to agreed-upon procedures, trackers, and templates.

• Collaborate with a senior team member to develop strategies and oversee setup activities, including Project Management Plans, joint operating procedures, POAs, and essential documents.

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

• Resolve problems and support the successful resolution of performance issues or delivery failures.

• Gather, review, track, and maintain the CVs, job descriptions, training records, contact information, and monthly reports of LCPs.

• Ensure appropriate training assignments are made and compliance with training requirements for LCPs.

• Confirm that all team members assigned to departmental deliverables for the project are aware of their tasks and allocated time, monitor project budgets, hours spent versus budgeted, and promptly identify and escalate any Out of Scope (OoS) issues.

• Assist in proposal development and budget input, providing departmental representation at BD meetings as necessary.

• Prepare client invoices and review or approve vendors’ 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 smooth and efficient service delivery.

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

• Participate in and/or assist junior team members in audit and inspection preparations, providing departmental representation for assigned projects as needed.

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

• Provide feedback regarding vendor performance to assist with their evaluation.

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

⛳️ Requirements

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

• Extensive experience in the pharmaceutical, CRO industry, or regulatory body.

• Comprehensive knowledge of ICH GCP and/or GVP, as well as national regulations relevant to the areas of expertise.

• PV training and/or practical experience, along with any other local educational or professional credentials as necessary.

• Proficient in English, both written and spoken.

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

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

• Excellent planning and organizational abilities.

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

• Keen 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 workplace atmosphere.

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