Senior Specialist, Regulatory & PV Network

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

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

• Lead and represent functional aspects for medium to high-complexity projects.

• Coordinate and oversee regulatory deliverables, ensuring teams meet targets and adhere to procedures.

• Develop strategies and manage project setup activities, including project management plans, joint operating procedures, POAs, and essential documents.

• Provide strategic insights to both internal and external stakeholders.

• Identify and mitigate risks through proactive measures.

• Solve problems and assist in resolving performance issues or delivery failures.

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

• Ensure proper training assignments and compliance by LCPs.

• Communicate project tasks and allocated time effectively to team members.

• Monitor project budgets, comparing actual hours spent to budgeted amounts, and escalate any out-of-scope issues.

• Assist in proposal development and budget management while representing the department in business development meetings.

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

• Train, coach, and mentor junior staff members.

• Cultivate professional relationships with internal and external contacts at both local and international levels.

• Monitor evolving regulatory legislative requirements and maintain the regulatory intelligence database.

• Disseminate relevant regulatory changes promptly.

• Participate in or assist with audit and inspection preparations.

• Track key performance indicators of LCPs and compile monthly summary reports.

• Provide feedback on vendor performance.

• Contribute to departmental and company initiatives, as well as design or review 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 with a Regulatory body.

• Strong understanding of ICH GCP and/or GVP and national regulations relevant to the areas of competency.

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

• Proficient in English, both written and spoken.

• Skilled in the official language of the country where they are based.

• Excellent planning and organizational capabilities.

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

• Keen attention to detail.

🏝️ Benefits

• Availability of remote work options.

• Flexible working environment.

• Opportunities for professional growth.

• Collaborative team atmosphere.

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

• Professional development opportunities through training, coaching, and mentoring.

• Join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.