Pharmacovigilance Physician II

TL;DR

Pharmacovigilance Physician II (Medical): Conducting medical assessment of safety data and aggregate safety reporting for biotech and pharma clients with an accent on regulatory compliance and risk management. Focus on ensuring medical accuracy of case narratives, signal detection, and supporting risk-benefit assessments for investigational and marketed products.

Location: Must be based in Spain

Company

A global research organization helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and diagnostics.

What you will do

• Conduct medical assessment of safety data including AEs, SAEs, and SUSARs.
• Ensure medical accuracy of case narratives and expedite case closure through query resolution.
• Write safety sections for aggregate reports such as PSURs, PADERs, and DSURs.
• Perform signal detection and risk-benefit assessments for investigational and marketed products.
• Contribute medically to Risk Management Plans (RMP) and REMS.
• Review study documentation and ensure adherence to ICH GCP and international regulatory standards.

Requirements

• Graduate in medicine required.
• Minimum 2 years of experience in a medical or safety department evaluating patient safety data.
• Fluent English proficiency required.
• Strong understanding of global PV regulatory environment, including FDA and EU GVP modules.
• Demonstrable knowledge of medical terminology and experience with safety databases like ARGUS.
• Must be based in Spain.

Nice to have

• Clinical practice experience in oncology, dermatology, pediatrics, or neuro-psychiatry.
• Previous experience working in a CRO environment.
• Familiarity with MedDRA and WHODRL coding.

Culture & Benefits

• Opportunity to work on life-changing medical innovations.
• Focus on professional growth and skill development.
• Supportive environment that values individual ideas and contributions.
• Commitment to work-life balance and flexibility.