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Our client is a company operating in the pharmaceutical business engaged in providing services to the industry peers, especially qualified and experienced in Business Development, Pharmacovigilance, Regulatory Affairs, GxP Compliance.
The core business is:
- Identify the best business partners.
- Identify the best product/source fit.
- Ensure European Pharmacovigilance Compliance.
- Meet the European GMP/GDP standards. Prepare, submit and/or maintain Marketing Authorisations in Europe.

DUE. ITS GROWTH, they need to cover an :
PHARMACOVIGILANCE DIRECTOR The Pharmacovigilance (PV) Director is a senior leadership role responsible for overseeing all drug safety and pharmacovigilance operations. In a services company, this includes managing client relationships, ensuring regulatory compliance, leading safety teams, and delivering high-quality PV services across multiple projects and sponsors.
Key Responsibilities
- Strategic Leadership
- In combination with top management,



Define and implement the company's pharmacovigilance strategy.
- Represent PV in internal and client meetings.
- Operational Oversight
- Supervise QPPV office, scientific literature screening, case processing, aggregate reporting, and risk management activities.
- Ensure compliance with applicable regulations.
- Oversee all other safety activities and quality control.
- Client & Project Management
- Ensure timely delivery of safety deliverables (e.G., PSURs, DSURs, RMPs).
- Support business development through proposals and client presentations.
- Regulatory Compliance
- Prepare for and lead audits and inspections.
- Ensure SOPs and processes align with current regulatory expectations.
- Manage safety exchange agreements and vendor oversight.
- Lead and mentor a team of PV professionals.
- Oversee training, performance reviews, and career development.
- Forecast staffing needs and manage resource allocation.

Qualifications
- Education: Un

📌 Director, Regulatory Affairs (Cataluña)
🏢 Richard Lombart Consulting & The Executive Way
📍 Cataluña