pharmacoviligance director

Our client is a 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 :

1. Identify the best business partners.
2. Identify the best product/source fit.
3. Ensure European Pharmacovigilance Compliance.
4. Meet the European GMP/GDP standards.Prepare, submit and/or maintain Marketing Authorisations in Europe.

DUE. ITS GROWTH, they need to cover an :

PHAMACOVIGILANCE DIRECTOR

Mataró ( Barcelona )

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

1. Strategic Leadership

• In combination with top management, Define and implement the company's

pharmacovigilance strategy.

• Represent PV in internal and client meetings.

1. 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.

1. Client & Project Management

• Ensure timely delivery of safety deliverables (e.g., PSURs, DSURs, RMPs).

• Support business development through proposals and client presentations.

1. 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.

1. Team Leadership

• Lead and mentor a team of PV professionals.

• Oversee training, performance reviews, and career development.

• Forecast staffing needs and manage resource allocation.

Qualifications

• Education: University degree in Medicine, Pharmacy or Life Sciences.

• Experience: +10 years in pharmacovigilance, with at least 5 years in a leadership role.

• • Industry: Experience in PV services environment is highly preferred.
• Languages : Fluent in English and Spanish.

We offer :

• Excelent salary package, according the experience
• Hibrid model work ( 2 days at work, 3 days at home ), with flexibility, it means, not mandatory
• The possibility to lead a competitive and challenging team