Regulatory Affairs & Pharmacovigilance Lead

PharmaLex; Madrid; On-site; EUR 42,000 - 66,000; Full time

Job summary

PharmaLex Spain S.L.U. in Madrid seeks an experienced pharmacovigilance professional to deliver client engagements and safety deliverables across the product lifecycle. You will coordinate case processing, review data, and maintain compliant documentation.

The role requires a life sciences degree and at least four years in pharmacovigilance or drug safety; certifications in PV, regulatory affairs, or quality management are preferred. The team emphasizes collaboration and quality.

Qualifications

• Bachelor's degree in life sciences or related field.
• 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting or regulatory affairs.
• PV certification preferred.
• Regulatory affairs certification preferred.
• Quality management or auditing certification preferred.

Responsibilities

• Deliver client engagements and safety deliverables within defined scope, quality, and timeline.
• Coordinate case processing, documentation, and handoffs to support compliant safety deliverables.
• Analyze safety data, literature, and other information for signal detection and risk assessment.
• Support development and maintenance of risk management deliverables and regulatory documentation.
• Guide less-experienced professionals in applying standards and procedures.

Skills

Pharmacovigilance

Safety analysis

Risk management

Client coordination

Regulatory affairs

Education

Bachelor's degree (life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs)

Job description

PharmaLex Spain S.L.U. in Madrid seeks an experienced pharmacovigilance professional to deliver client engagements and safety deliverables across the product lifecycle. You will coordinate case processing, review data, and maintain compliant documentation.

The role requires a life sciences degree and at least four years in pharmacovigilance or drug safety; certifications in PV, regulatory affairs, or quality management are preferred. The team emphasizes collaboration and quality.