Pharmacovigilance Specialist (6-Month Interim Project)
Location: Madrid, Spain (Hybrid: office-based & home-based flexibility)
Company: Oxford Global Resources – Life Sciences Consulting
Oxford Global Resources Consulting is currently looking for a Pharmacovigilance Specialist to join the team of one of our clients in Madrid. This is an interim project of 6 months, offering flexible working conditions with a combination of office and remote work .
This role will support the local pharmacovigilance system, ensuring regulatory compliance and high standards of safety monitoring for marketed products and medical devices.
Key Responsibilities
Pharmacovigilance Operations
* Handle safety information for marketed products ensuring compliance with local regulatory requirements.
* Manage Individual Case Safety Reports (ICSRs) including:
* Case narrative writing and editing
* Duplicate search
* Case follow-up and follow-up letters
* Quality control of safety data entered into PV databases
* Tracking and archiving safety information
* Review and monitor the affiliate pharmacovigilance mailbox during working days.
* Monitor Registration Sales Tools for safety information.
Safety Monitoring & Compliance
* Manage local literature surveillance follow-up and ensure valid cases are processed appropriately.
* Handle safety information related to clinical devices .
* Manage device incident reporting and ensure compliance until full implementation of EUDAMED .
* Assist in maintaining the local Pharmacovigilance Quality Management System (QMS) .
Quality & Reporting
* Ensure quality and compliance of pharmacovigilance deliverables .
* Support preparation for audits and inspections and maintain the PV system inspection-ready.
* Analyze safety data, identify trends, and flag anomalies for corrective action.
Cross-Functional Collaboration
* Interact with internal teams and vendors to ensure efficient processing of adverse events and safety data .
* Support safety reconciliation activities with vendors.
* Provide internal and external pharmacovigilance training and awareness .
Complaints & Safety Escalation
* Manage technical complaints and customer responses, including product replacements when applicable.
* Escalate potential counterfeit products, illegal sales, or legal complaints to internal stakeholders and local health authorities when necessary.
Requirements
* University degree in Health Sciences (Pharmacy, Medicine, Biology, or similar).
* Minimum 4 years of experience in Pharmacovigilance and/or Clinical Research.
* Strong understanding of drug safety regulations and PV processes .
* Excellent written and verbal communication skills in English .
* Strong attention to detail and quality-focused mindset.
* Ability to work independently while collaborating with cross-functional teams.
* Strong organizational and time management skills with the ability to work under strict timelines.
What We Offer
* Hybrid work model ( home-working flexibility )
* Meal vouchers (ticket restaurant)
* English classes
* Opportunity to work on a high-impact pharmacovigilance project in the Life Sciences sector