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

📋 Description

• Lead the Pharmacovigilance (PV) Medical Writing function, ensuring the delivery of high-quality, compliant, and timely outputs.

• Manage and nurture the PV Medical Writing team, promoting performance, engagement, and professional development.

• Champion initiatives for quality, compliance, inspection readiness, and continuous improvement, overseeing SOPs, KPIs, audits, and regulatory inspections.

• Offer strategic expertise in PV medical writing and subject matter leadership to clients, internal stakeholders, and project teams.

• Assist in business development efforts, including proposals, bid defenses, and client interactions.

• Supervise departmental resources, budgets, and operational performance to guarantee efficient service delivery.

• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other essential pharmacovigilance deliverables.

• Establish and maintain robust client relationships, ensuring outstanding service and trusted partnerships.

• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

⛳️ Requirements

• Significant experience in pharmacovigilance and PV Medical Writing, including leadership and management of high-performing teams.

• In-depth understanding of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.

• Demonstrated experience in supporting regulatory compliance, inspections, and oversight of pharmacovigilance systems, including QPPV or Deputy QPPV roles.

• Strong business acumen with experience in supporting proposals, client engagements, and bid defense initiatives.

• Exceptional scientific, regulatory, and analytical skills, including the ability to transform complex clinical and safety data into clear, high-quality regulatory and scientific documents.