Senior Specialist, Regulatory – PV Network

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

📋 Description

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

• Take the lead and represent functional interests for projects of medium to high complexity, ensuring efficient 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 formulate strategies and oversee setup activities (including Project Management Plans, joint operating procedures, POAs, and essential documents).

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

• Resolve issues proactively and assist in ensuring satisfactory outcomes for performance challenges or delivery shortcomings.

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

• Guarantee appropriate training assignments and ensure compliance with training requirements for the LCPs.

• Ensure that all team members involved in departmental deliverables are informed of their tasks and allocated time, monitor project budgets, hours spent versus budgeted hours, and quickly identify and escalate any Out of Scope (OoS) situations.

• Assist in the development of proposals and budget inputs, and represent the department in Business Development meetings as necessary.

• Prepare client invoices and review/approve invoices submitted by vendors for projects.

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

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

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

• Participate in and/or assist junior members in audit/inspection preparations and represent the department for assigned projects as needed.

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

• Offer feedback on vendor performance to support their evaluation.

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

⛳️ Requirements

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

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

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

• PV training and/or relevant work experience along with any additional educational or professional qualifications as required locally.

• Proficient in English, both in written and spoken form.

• 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 beneficial but not essential.

• Excellent planning and organizational abilities.

• Strong interpersonal skills suited for a fast-paced, deadline-driven, and dynamic environment.

• Keen attention to detail.

🏝️ Benefits

• Opportunities for training and career advancement within the organization.

• A strong focus on personal and professional development.

• A friendly and supportive work environment.

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