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

📋 Description

• Lead the PV Medical Writing department, ensuring that deliverables are of high quality, compliant, and delivered in a timely manner.

• Manage and develop the PV Medical Writing team, promoting performance, engagement, and professional growth.

• Drive initiatives related to quality, compliance, inspection readiness, and continuous improvement, overseeing SOPs, KPIs, audits, and regulatory inspections.

• Offer strategic expertise in PV medical writing and serve as a subject matter leader for clients, internal stakeholders, and project teams.

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

• Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery.

• Review regulatory safety responses and aid in the development of Risk Management Plans, aggregate reports, and other critical pharmacovigilance deliverables.

• Establish and maintain strong relationships with clients, guaranteeing exceptional service and trusted partnerships.

• Represent the organization in external engagements through industry participation, publications, presentations, and professional development activities.

⛳️ Requirements

• Extensive 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 responsibilities.

• Strong business acumen and experience in supporting proposals, client interactions, and bid defense activities.

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