Pharmacoviligance Director

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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: 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.

Benefits

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

Seniority level

Director

Employment type

Full-time

Industries

Human Resources Services

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