Safety Data Specialist, Global Patient Safety, Digital & Technology

Jobtailor

Søborg

On-site

DKK 900,000 - 1,200,000

Full time

9 days ago
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Job summary

Jobtailor seeks a senior Pharmacovigilance professional to lead safety data extracts and ensure compliance with regulatory requirements. You will work with clinical and IT teams to plan inspections, improve data quality, and support post-implementation hypercare across Global Patient Safety.

The ideal candidate has 7–8 years in pharmacovigilance, strong knowledge of E2B(R3) standards, and excellent English.

Qualifications

  • Master’s degree in science, pharmaceutical sciences or health sciences.
  • 7–8 years experience in pharmacovigilance or drug safety.
  • Knowledge of safety data requirements and regulations.
  • Experience with E2B(R3) standards.
  • Strong English written and spoken.
  • Ability to work independently with multiple priorities.
  • Experience with safety data extracts or inspections is a plus.

Responsibilities

  • Shape safety data extracts and BI solutions.
  • Plan and coordinate extracts for Health Authority inspection pre-requests.
  • Coach and share knowledge to build organisational capability.
  • Support hypercare after system implementations and releases.
  • Drive knowledge-sharing and continuous improvement initiatives.
  • Strengthen data quality and inspection readiness.
  • Collaborate with SMEs, developers and stakeholders across Global Patient Safety.

Skills

Pharmacovigilance
Data management
E2B(R3)
Regulatory knowledge
Analytical skills
English proficiency
Independent work
Prioritization

Education

Master’s Degree in Science
Master’s Degree in Pharmaceutical Sciences
Master’s Degree in Health Sciences

Tools

System Implementations
Business Intelligence

Job description

  • Shape safety data extracts and business intelligence solutions with application developers
  • Plan and coordinate safety data extracts for Health Authority inspection pre-requests with business domain specialists
  • Coach, guide and share knowledge to build organisational capability
  • Support hypercare activities following system implementations and releases
  • Drive knowledge-sharing and continuous improvement initiatives
  • Strengthen data quality and inspection readiness
  • Improve the effective and consistent use of safety data across Global Patient Safety
  • Collaborate with subject matter experts, application developers and stakeholders across Global Patient Safety
Requirements
  • A Master’s degree in Science, Pharmaceutical Sciences, Health Sciences or a related discipline
  • At least 7-8 years of experience within pharmacovigilance, drug safety or a closely related area
  • Strong knowledge of safety data requirements and regulations
  • Practical experience with standards such as E2B(R3)
  • Broad understanding of end-to-end pharmacovigilance regulatory requirements
  • Excellent written and spoken English
  • Strong analytical capabilities
  • Ability to work independently while managing multiple priorities
  • Experience with safety data extracts, inspections, digital solutions or system implementations within pharmacovigilance will be considered an advantage
Core Competencies

Demonstrates expertise in pharmacovigilance and drug safety, with a strong focus on safety data management, regulatory compliance, and continuous improvement initiatives. Capable of collaborating effectively with cross-functional teams and stakeholders to enhance data quality and inspection readiness.

Highest-signal resume keywords
  • Pharmacovigilance Experience
  • Safety Data Management
  • E2B(R3) Standards
  • Regulatory Compliance
  • Analytical Capabilities
Hard Skills
  • Safety Data Extracts
  • Drug Safety
  • Pharmacovigilance
  • Data Quality Improvement
  • System Implementations
  • Business Intelligence Solutions
  • Health Authority Regulations
  • Digital Solutions
Soft Skills
  • Coaching
  • Knowledge Sharing
  • Independent Work
  • Prioritization
Certifications & Qualifications
  • Master’s Degree in Science
  • Master’s Degree in Pharmaceutical Sciences
  • Master’s Degree in Health Sciences
Industry Keywords
  • Safety Data Requirements
  • Inspection Readiness
  • Global Patient Safety
  • Continuous Improvement Initiatives
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