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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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