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