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 functionally manage medium to high-complexity projects.

• Coordinate and oversee regulatory deliverables, guiding teams to achieve targets and adhere to procedures.

• Formulate regulatory and pharmacovigilance strategies and oversee project setup activities.

• Offer strategic insights to both internal and external stakeholders.

• Identify and mitigate risks through proactive measures.

• Address performance issues and resolve delivery failures.

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

• Ensure compliance with LCP training assignments.

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

• Monitor project budgets, compare hours worked against budgeted hours, and escalate any out-of-scope work.

• Assist in proposal development, budgeting, and business development meetings.

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

• Train, coach, and mentor junior staff members.

• Foster professional relationships with internal and external contacts both locally and internationally.

• Stay updated on changing regulatory legislative requirements and maintain the regulatory intelligence database.

• Prepare for audits/inspections and represent the department during these processes.

• Track LCP KPIs and compile monthly summary reports.

• Provide feedback on vendor performance.

• Contribute to departmental and company initiatives, and design or review standard operating procedures (SOPs), working practices, and guidance.

⛳️ Requirements

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

• Significant experience in the pharmaceutical or CRO industry, or with a regulatory body.

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

• PV training and/or relevant work experience, plus any additional educational or professional qualifications required locally.

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

• Fluent in the official language of the country of residence.

• Strong planning and organizational abilities.

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

• High attention to detail.

🏝️ Benefits

• Opportunity for remote work.

• A collaborative and supportive team atmosphere.

• Flexible work culture.

• Opportunities for growth and professional development.

• Access to training, coaching, and mentoring programs.

• Chance to contribute to company initiatives and the development of SOPs, working practices, and guidance.

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

• Opportunity to assist in delivering safe and effective pharmaceutical treatments to patients worldwide.